National Institute of Allergy and Infectious Diseases (NIAID)

  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:554ee5b785482f20a95b335f9530a813' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:554ee5b785482f20a95b335f9530a813' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:806dd398f231d42ce749c9ae60799f0b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f74042675445a140df5f5939d2481400' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI) has not kept pace with the emergence of Methicillin-Resistant Staphylococcus aureus (MRSA) in the community. This clinical trial will evaluate Clindamycin (CLINDA) and Trimethoprim-Sulfamethoxazole (TMP-SMX) and wound care for the outpatient management of uSSTI in 3 metropolitan areas, Chicago, Los Angeles, and San Francisco, cities with high prevalence of community acquired (CA)-MRSA. This is a phase IIb multicenter, stratified, randomized, double-blind trial in which enrolled subjects with abscess or cellulitis will be treated with either CLINDA, TMP-SMX, or placebo. Participants will include 1310 non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission. Subjects will undergo a screening/baseline evaluation, including determination of presence and size of abscess and/or presence of cellulitis. Subjects will then be randomized to receive treatment with either CLINDA, TMP-SMX, or placebo depending on whether they have: a larger drainable abscess, defined as greater than 5 cm in diameter in adults and as greater than 3 cm in diameter for ages 6-11 months, greater than 4 cm for ages 1-8 years, and greater than 5 cm for age 9 years and older; a limited drainable abscess, defined as less than or equal to 5 cm for adults and as less than or equal to 3 cm for ages 6-11 months, less than or equal to 4 cm for ages 1-8 years, and less than or equal to 5 cm for age 9 years and older; or cellulitis or erysipelas only. If the diameter of the abscess greater than 5 cm (smaller for children depending on age) or 2 or more sites of skin infection are present the subject will be randomized (1:1) to 10 days of therapy with TMP-SMX or CLINDA. If the diameter of the abscess less than or equal to 5 cm (smaller for children depending on age) then the subject will be randomized (1:1:1) to TMP-SMX, CLINDA or placebo for 10 days. Subjects with cellulitis or erysipelas only will be randomized (1:1) to TMP-SMX or CLINDA for 10 days. Subjects will be provided study drug, instructed in its use, and scheduled for 4 follow-up visits including: wound check (24-48h after enrollment); end of therapy (48h after completion of therapy); test of cure (7-10 days after completion of therapy); and a final visit at one month after completion of therapy. The primary objectives of this study are: to compare the cure rate of CLINDA to that of TMP-SMX for the treatment of patients with cellulitis or larger abscess at the Test of Cure (TOC) visit and to compare the cure rate of CLINDA, TMP-SMX, and placebo, each in conjunction with surgical drainage for the treatment of subjects with limited abscess at the TOC visit. The primary efficacy endpoint for the trial is clinical cure, which is the absence of clinical failure. The secondary objectives are: to estimate the cure rates of CLINDA and of TMP-SMX, and their difference, for limited abscess, cellulitis, or larger abscess: at the End of Treatment (EOT) visit, one month follow-up (OMFU) visit, in children and adults at the TOC visit; and for children versus adults at the TOC visit; to compare rates of adverse events and of adverse events that are treatment limiting between CLINDA and TMP-SMX for limited abscess, cellulitis, or larger abscess: at the TOC visit, EOT visit, and for children and adults separately at the TOC visit; and to estimate rates of adverse events and of adverse events that are treatment limiting for CLINDA and for TMP-SMX for limited abscess, cellulitis, or larger abscess for children, for adults, and the difference between children and adults. Secondary efficacy endpoints are: clinical cure at the EOT visit and clinical cure at the OMFU visit. Study duration will be for 3 years with subject participation duration equal to 6 weeks.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:f74042675445a140df5f5939d2481400' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Age 6 months to 85 years.</li>\n<li>Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 7 and older.</li>\n<li>Willing and able to complete the study protocol, study-related activities, and visits.</li>\n<li>Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours: Erythema Swelling or induration Local warmth Purulent drainage Tenderness to palpation or pain</li>\n<li>Able to take oral antibiotic therapy, either in pill or suspension form.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Hospital in-patient.</li>\n<li>Hospitalization within the prior 14 days.</li>\n<li>Residence in a long-term skilled nursing facility.</li>\n<li>Requirement for hospitalization for skin infection or other condition.</li>\n<li>Previous enrollment in this protocol.</li>\n<li>Participation in another clinical trial within the previous 30 days or plans to enroll in another clinical trial during the study period.</li>\n<li>Superficial skin infection only, including: impetigo, ecthyma, folliculitis, or infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures.</li>\n<li>Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements.</li>\n<li>Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements.</li>\n<li>Systolic blood pressure &gt; 180 mm Hg</li>\n<li>Systolic blood pressure (SBP) less than an age-specific critical value:</li>\n</ul>\n</p><p> Age 6 -11 months: &lt; 70 mm Hg Age 1 to 8 years: &lt; 80 mm Hg Age 9 to 17 years: &lt; 90 Age greater than or equal to 18 years: &lt; 90 mm Hg\n<ul>\n<li>Heart rate less than 45 beats per minute (BPM).</li>\n<li>Heart rate greater than an age-specific critical value:</li>\n</ul>\n</p><p> Age 6 -11 months: &gt; 140 beats BPM Age 1 to 8 years: &gt; 120 BPM Age 9 to 17 years: &gt; 120 BPM Age greater than or equal to 18 years: &gt; 120 BPM.\n<ul>\n<li>Oral temperature less than 35.5 degrees C (95.9 degrees F).</li>\n<li>Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:</li>\n</ul>\n</p><p> Age 6 -11 months: &gt; 38.0 degrees C (100.4 degrees F) Age 1 to 8 years: &gt; 38.5 degrees C (101.3 degrees F) Age 9 to 17 years: &gt; 38.5 degrees C (101.3 degrees F) Age greater than or equal to 18 years: &gt; 38.5 degrees C (101.3 degrees F).\n<ul>\n<li>Human or animal bite in the past 30 days at the site of infection.</li>\n<li>Antimicrobial treatment within the prior 14 days.</li>\n<li>The following concomitant medications: warfarin, phenytoin, or methotrexate.</li>\n<li>Diagnosed or suspected disseminated or severe S. aureus or GAS infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infections.</li>\n<li>Infection at an anatomical site skin requiring specialized management or specialized antimicrobial therapy, including Periauricular or orbital infection Perirectal infection within 2 cm of the anus Suspected deep space infection of the hand or foot Genital infection</li>\n<li>Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician).</li>\n<li>Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics.</li>\n<li>Hypersensitivity or history of allergic reaction to study drug.</li>\n<li>History of G6PD deficiency.</li>\n<li>Third trimester pregnancy: pregnant women must have gestational age estimated by an objective means, e.g. ultrasound, fundal height, and women who are within 4 weeks of the third trimester of pregnancy, defined as week 27 of pregnancy, are not eligible.</li>\n<li>Severe or morbid obesity with a body mass index (BMI) greater than or equal to 35 kg/m^2.</li>\n<li>Complicated skin or soft tissue infection, such as Catheter or catheter site infection within 30 days of placement Surgical site infection Known or suspected prosthetic device infection Suspected Gram-negative or anaerobic pathogen Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc) Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis</li>\n<li>History of underlying immunocompromising condition or immunodeficiency, for example Diabetes mellitus Chronic renal failure, creatinine clearance &lt;30 ml/min Renal dialysis within the past 180 days HIV-positive with either CD4 count &lt;200 or &lt;4% CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease Other serious underlying disease, as determined by the treating physician or the investigator</li>\n</ul>\n</p>', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:c9792e003f3e74502cbe31e13b927c57' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Safety outcomes: adverse events; and adverse events that are treatment limiting. [&nbsp;Time&nbsp;Frame:&nbsp;Duration of study.&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:30e59598f095b49fd5350c34fbfc786a' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Efficacy outcome: clinical cure. [&nbsp;Time&nbsp;Frame:&nbsp;Within 48 hours of completion of therapy; 1 month follow up.&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:59d53fec7f66eb84f22fc999486415ef' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:11aa747b6b1d0cad62817fc2ef3d97a2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 1,590 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:11aa747b6b1d0cad62817fc2ef3d97a2' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus (&quot;STOP MRSA&quot;) - A Phase IIB, Multi-Center, Randomized, Double-Blind, Clinical Trial</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:a8f888a0e02e8b8e60783ec81e881aa2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:2b92f90f0ec662f5954d645164fb8ece' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This is a multi-center, randomized, double-blind clinical trial in which patients will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs. Subjects with an acute uncomplicated cutaneous abscess receiving Incision and Drainage (I&amp;D) will be treated with TMP/SMX (Trimethoprim/Sulfamethoxazole) or placebo to determine whether the addition of an antibiotic with activity against CA-MRSA (Community-Acquired Methicillin-Resistant Staphylococcus aureus) is more clinically efficacious than I&amp;D alone. Subjects with an acute uncomplicated wound infection will be treated with TMP/SMX or clindamycin to determine if clindamycin is more clinically efficacious than TMP/SMX. Subjects with acute uncomplicated cellulitis will be treated with cephalexin and TMP/SMX or cephalexin and placebo to determine if cephalexin and TMP/SMX are more clinically efficacious than cephalexin alone. The study population will include children 13 years of age and over and adults, who weigh greater than or equal to 40 kg presenting to 5 large urban EDs (Emergency Department). Therapy will start on the day of enrollment. Subjects will be evaluated upon enrollment, at 2-3 days after enrollment (OTV), at 1-3 days after the end-of-therapy (EOT), and at 7-14 days after the end-of-therapy (TOC), and at 6-8 weeks after the end-of-therapy (EFV). The primary efficacy endpoint will be clinical outcome (i.e., cure or failure) at the TOC in the PP population. Secondary endpoints will include microbiological cure, change in the dimension of erythema, composite cure, surgical procedures, invasive and recurrent infections, infections in household contacts, and time to normal activity and until analgesics are no longer used at various times in the PP/ Modified Intent-to-Treat populations.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:2b92f90f0ec662f5954d645164fb8ece' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cedefda3404f2814f89871eb86ad8fff' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);</li>\n<li>Have a Skin and Soft-Tissue Infection (SSTI) with all three local findings of erythema (&gt; 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:\n<ol>\n<li>Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving Incision and Drainage (I&amp;D) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant)</li>\n<li>Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-peritoneal surgery, and</li>\n<li>Cellulitis - an area of erythema without the presence of a wound with drainage or abscess;</li>\n</ol>\n</li>\n</ul>\n</p><p> Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded.\n<ul>\n<li>Have the infected lesion for 7 days or less duration;</li>\n<li>Are to receive outpatient treatment;</li>\n<li>Express willingness and ability to be contacted and return for re-evaluation according to the study protocol;</li>\n<li>Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent);</li>\n<li>Negative pregnancy test for subjects who are women of childbearing potential.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Severe allergy or reaction to study drug or drugs similar to the study drug relevant to whichever study arm the subject would be assigned to (e.g., patients with severe or life-threatening penicillin allergies, allergy to any cephalosporin, clindamycin, or sulfonamides, or any other drug containing sulfur such as thiazides, furosemide, and oral sulfonylureas).</li>\n<li>Concomitant treatment with coumadin, phenytoin, or methotrexate, or suspected G-6-PD or folic acid deficiency.</li>\n<li>Expected inability to swallow or absorb the study drug (assessed by patient history).</li>\n<li>Pregnancy, nursing, or expectation of becoming pregnant during the treatment period.</li>\n<li>Perirectal (within 5 cm of anus), perineal non-skin lesions. (i.e., mucosal), or paronychial location of infection. Scrotal and labial abscesses will not be excluded.</li>\n<li>An infection due to a mammalian bite.</li>\n<li>Treatment with a study drug relevant to their infection type, or another systemic antibiotic in the previous 48 hours unless associated with treatment failure which is defined as a patient who has been on prior (non study drug) antibiotics for at least 72 hours and failed.</li>\n<li>Expected concurrent treatment with a topical antibiotic or another systemic antibiotic.</li>\n<li>Immunodeficiency (e.g., absolute neutrophil count &lt;500/mm^3, chronic immunosuppressive drugs, active chemotherapy, or known AIDS or AIDS-defining illness within the last year; assessed by patient history).</li>\n<li>Burn or active chronic skin condition (e.g., including rash or eczema) related to the Skin and Soft-Tissue Infection (SSTI).</li>\n<li>Infection related to percutaneous prosthetic device (e.g., intravenous line), excepting sutures associated with qualifying infected wounds which will be removed upon enrollment.</li>\n<li>Infection for which prior cultures reveal in vitro resistance of a pathogen to a study drug in the previous month.</li>\n<li>Known or suspected osteomyelitis or septic arthritis.</li>\n<li>Infection related to diabetic foot, decubitus, or ischemic ulcer.</li>\n<li>Known severe renal insufficiency (creatinine clearance &lt; 50 mL/min) calculated by measurement of serum creatinine if patient provides this history or based on past studies).</li>\n<li>Prior enrollment in this study within 12 weeks.</li>\n<li>Another active infection or more than one active SSTI site.</li>\n<li>Presence of an abscess that has completely drained, either spontaneously or by a healthcare provider prior to enrollment.</li>\n<li>An infected wound or cellulitis that has been surgically explored and does not reveal an abscess.</li>\n<li>Currently incarcerated in a detention facility.</li>\n<li>For patients with an infected wound, history of C. difficile infection, pseudomembranous colitis, or active diarrhea.</li>\n<li>For patients with an infected wound, severe liver disease based on patient history.</li>\n<li>An intravenous (IV) drug user in the last month with current presence of fever.</li>\n<li>Current residence in a nursing home or other long term care facility.</li>\n<li>Use of other investigational drug or vaccine.</li>\n<li>For patients with an abscess, cardiac conditions associated with the highest risk of adverse outcome from endocarditis for which prophylaxis is reasonable including patients with prosthetic cardiac valve or prosthetic material used for cardiac valve repair, history of previous infective endocarditis, congenital heart disease (excluding mitral valve prolapse), and history of cardiac transplantation recipients who develop cardiac valvulopathy.</li>\n</ul>\n</p>', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:cedefda3404f2814f89871eb86ad8fff' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:3e3a59380d4417367da722048e896f40' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:49f80eba190b58415060549ecef723f7' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:49f80eba190b58415060549ecef723f7' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8d4e77a1c68910f23c6bbcfd0da9d328' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo. This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 33 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy. Study visits will occur every 6 months after enrollment. A nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:8d4e77a1c68910f23c6bbcfd0da9d328' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:f6bbe5de1ada4c9608064644f65e744d' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Enrolled in MTN-003</li>\n<li>Randomized to oral study product in MTN-003 within 14 days prior to study entry</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Medical condition known to affect bone or taking any medication known to affect bone. More information on this criterion can be found in the protocol.</li>\n<li>Permanently discontinued from oral study product in MTN-003 prior to study entry</li>\n<li>Any condition that, in the opinion of the investigator, would interfere with the study</li>\n<li>Pregnant</li>\n</ul>\n</p>', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:f6bbe5de1ada4c9608064644f65e744d' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:c47e9c7a8471a06a5ff0bfa9c35e3eca' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study, conducted in Masan, South Korea, will investigate the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular medicines do not work well against XDR TB, many more people die from it than from regular TB, which can be successfully treated by taking TB medication for 6 months. Linezolid has been used to treat other kinds of infections, but has not been well studied for TB. This study will look at the side effects and effectiveness of prolonged treatment with linezolid at two different doses. People 20 years of age and older who have XDR TB may be eligible for this 3-year study. Participants undergo the following tests and procedures:\n<ul>\n<li>LZD treatment: Patients are randomly assigned to one of two study groups. Group 1 patients are observed for 2 months before starting LZD, while group 2 patients begin taking LZD right away. Both groups begin with a 600 mg daily dose of LZD. After patients stop coughing up TB germs (or after 4 months on LZD) they are randomly assigned either to continue taking 600 mg of LZD for the rest of the study or to take a decreased dose of 300 mg. In addition to LZD, patients continue to take their currently prescribed TB medications.</li>\n<li>Medical history.</li>\n<li>Physical examinations each month during treatment.</li>\n<li>Sputum collections once a week or more until 3 weeks after the patient is no longer contagious.</li>\n<li>Blood draws every week for 16 to 24 weeks and then once a month.</li>\n<li>Urine collections at several time points.</li>\n<li>Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects.</li>\n<li>CT scans of the lungs three to four times the first year and once more later in the study. For this test the patient lies on a table within the doughnut-shaped CT scanner while special X-ray pictures are taken.</li>\n</ul>\n</p><p> Patients who participate in a substudy will have PET scans instead of the CT scans. For this test, the patient is given an injection into a vein of a radioactive chemical that can be detected by a special camera and viewed on a screen. The patient lies on a table within the doughnut-shaped scanner while pictures are taken.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:c47e9c7a8471a06a5ff0bfa9c35e3eca' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:95f8280f32adc8c4e1cd6a8e55bfebd2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose of this study is to determine the immune response to a yellow fever vaccine in adults with AD.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:95f8280f32adc8c4e1cd6a8e55bfebd2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:88b132e95bef6cc42f9b71c4a8cac6cb' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Adverse events [&nbsp;Time&nbsp;Frame:&nbsp;throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:88b132e95bef6cc42f9b71c4a8cac6cb' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8d9ddb94f19fc57a9ebe160ad2bd3e5e' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Kinetics of antibody responses to YFV (CMax, TMax, area under the curve) [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:8d9ddb94f19fc57a9ebe160ad2bd3e5e' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:845c47bc5faad2acef98de878edef06b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Kinetics and magnitude of YFV-specific CD4 and CD8 cell responses as measured by intracellular cytokine staining [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:845c47bc5faad2acef98de878edef06b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:cc1bd5f0937007c3299fc39f7a5cf4e3' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Th1 and Th2 cytokine production [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:cc1bd5f0937007c3299fc39f7a5cf4e3' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:dcdbfa3299c321640ef986ec89a8e782' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>NK cell enumeration [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:dcdbfa3299c321640ef986ec89a8e782' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ff62f87f892b2267292402836e7d552b' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Detection of virus shedding at the TC vaccination site [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:ff62f87f892b2267292402836e7d552b' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d874f9fcb97bfab76adcaba0a13953a0' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Local inflammation at vaccination site [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:d874f9fcb97bfab76adcaba0a13953a0' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8ba3362e1d607137027c536545827e73' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Clinical laboratory tests (blood count, liver function, renal function) [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:8ba3362e1d607137027c536545827e73' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:613dc87140866d133b9ee2e90ef83805' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Measurement of complement levels and function [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:613dc87140866d133b9ee2e90ef83805' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0f2d5d7322e5dde61f3d90fcdcd96c50' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:0f2d5d7322e5dde61f3d90fcdcd96c50' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9ebc56b5fb129383aebfe02ddd57f5e2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Amount of vaccine virus shed by each participant [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:9ebc56b5fb129383aebfe02ddd57f5e2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:aba8dd514c1012957fc328b060678a5a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Phenotypic stability of vaccine virus shed [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:aba8dd514c1012957fc328b060678a5a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:7cff4eb23fbf6b33b584f9f00691629a' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Frequency of vaccine-related reactogenicity events and other adverse events [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:7cff4eb23fbf6b33b584f9f00691629a' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:90d2148524a2c71c9239b61ccb0ddb70' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Amount of serum and nasal wash antibody induced by the vaccine [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:90d2148524a2c71c9239b61ccb0ddb70' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:9e92a18dd2eb5a1f5001446d11e27d23' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Number of participants infected with the H2N2 1960 AA ca recombinant vaccine [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:9e92a18dd2eb5a1f5001446d11e27d23' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0012927b144feb58423f088b5f86b367' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>T-cell mediated and innate immune responses against the H2N2 1960 AA ca recombinant vaccine [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:0012927b144feb58423f088b5f86b367' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:e3e469c1e8cc2dfbbc760f540781c4e5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis. Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact with an allergy-causing substance, usually a particular food, drug or stinging insect. The allergen triggers mast cells to release several substances, including histamine. Histamine is responsible for many of the symptoms that may occur, such as flushing, hives, swelling of the palms and soles or tongue and vocal cords, nasal congestion, itching and tearing of the eyes, shortness of breath and wheezing, stomach pain, vomiting, low blood pressure, loss of consciousness, shock, and, rarely, death. Severe episodes of anaphylaxis are treated with epinephrine (adrenaline), followed by oral antihistamines and steroids. In more than half of cases of anaphylaxis, a clear cause is not identified. These cases are called idiopathic anaphylaxis. There is no cure or long-term preventive therapy for patients with recurrent episodes of idiopathic anaphylaxis. People between 18 and 55 years of age who have idiopathic anaphylaxis episodes at least 6 times a year (with at least one episode every 3 months) may be eligible for this study. Participants are evaluated at the NIH Clinical Center with the following tests and procedures:\n<ul>\n<li>Medical history, physical examination and blood tests.</li>\n<li>Bone marrow biopsy. For this test, the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia. Then, a needle is inserted into the hipbone and a small amount of bone marrow is drawn into a syringe. The needle also cuts a small core of bone marrow, which is removed for analysis.</li>\n<li>Other tests that may be needed for evaluation of the patient\'s condition.</li>\n</ul>\n</p>', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:e3e469c1e8cc2dfbbc760f540781c4e5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1f96993880038c40fd9435aee99d6f4f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other\'s progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:1f96993880038c40fd9435aee99d6f4f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:8234d02d5a5dd8b2e3335b2419e1e67f' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:8234d02d5a5dd8b2e3335b2419e1e67f' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:85021526298786eedac247d062b1e4a8' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens. This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060. This substudy will last until 24 weeks after the last P1060 enrollment or until P1060 study discontinuation. Participants must meet enrollment criteria for P1060 as well as additional criteria for this study. Study visits will occur as a part of P1060 study visits, all of which include a physical exam, blood collection, and assessments of HIV-related symptoms. Participants are also encouraged to return to the primary clinic site for intercurrent illness visits for assessment, thick and thin blood smear, and filter paper blood collection, however these visits are not mandatory for study participation.</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:85021526298786eedac247d062b1e4a8' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:381295db8f5603cbd4bf113e234a90d9' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Enrolling in study IMPAACT P1060</li>\n<li>Parent/legal guardian agrees to seek medical care for intercurrent illness at the study site, whenever possible, and agree to not use at-home remedies for febrile illness in the child</li>\n</ul>\n</p>', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:381295db8f5603cbd4bf113e234a90d9' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:ac7b42d8a6ca4119bfc950ef41286955' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Time of initiation of treatment for clinical malaria requiring conventional anti-malarial therapy [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:ac7b42d8a6ca4119bfc950ef41286955' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:6d03849f4f85c16f18bd6ea531141ed5' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Severity of malarial disease [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;Yes&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:6d03849f4f85c16f18bd6ea531141ed5' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:0f1647a990276829726e0409bd5e2650' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Measured anti-malaria IgG, protein in plasma, and mRNA transcripts in PBMC of chemokines [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:0f1647a990276829726e0409bd5e2650' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:d99a92c713103e00334fa529383ed4d2' in /persistent/html/includes/cache.inc on line 26.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>IL4-589C/T genotypes [&nbsp;Time&nbsp;Frame:&nbsp;Throughout study&nbsp;] [&nbsp;Designated&nbsp;as&nbsp;safety&nbsp;issue:&nbsp;No&nbsp;]</p>\n', created = 1283569328, expire = 1283655728, headers = '', serialized = 0 WHERE cid = '1:d99a92c713103e00334fa529383ed4d2' in /persistent/html/includes/cache.inc on line 109.
  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: SELECT data, created, headers, expire, serialized FROM cache_filter WHERE cid = '1:1ba575c9e05a13c6375fe14bed81856c' in /persistent/html/includes/cache.inc on line 26.
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Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this clinical trial is to evaluate 2 different antibiotics, drugs that fight bacteria, [clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX)] and wound care for the outpatient management of uncomplicated skin and soft tissue infections (uSSTIs) in children and adults. The study will occur in areas where community associated methicillin-resistant Staphylococcus (S.) aureus are common. S. aureus is a type of bacteria. A total of 1310 volunteers, greater than or equal to 6 months of age, non-immunocompromised, with uSSTIs (in particular abscess and/or cellulitis) will be enrolled in this study. Subjects will be treated with one of the following: CLINDA, TMP-SMX, or placebo (contains no medication). Volunteers will be grouped based on the presence of cellulitis or abscess, whether the abscess can be surgically drained, and its size. The subject participation duration for this study is about 6 weeks.

Background information
Trial ID: 
NCT00730028
Other unique IDs: 
07-0051
UCSF CA-MRSA
Official title: 

Randomized, Double-Blind Trial of Clindamycin, Trimethoprim-Sulfamethoxazole, or Placebo for Uncomplicated Skin and Soft Tissue Infections Caused by Community-Associated Methicillin-Resistant Staphylococcus Aureus

Detailed description: 

Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI) has not kept pace with the emergence of Methicillin-Resistant Staphylococcus aureus (MRSA) in the community. This clinical trial will evaluate Clindamycin (CLINDA) and Trimethoprim-Sulfamethoxazole (TMP-SMX) and wound care for the outpatient management of uSSTI in 3 metropolitan areas, Chicago, Los Angeles, and San Francisco, cities with high prevalence of community acquired (CA)-MRSA.

Number to be enrolled: 
1310 patients

Strategies Using Off-Patent Antibiotics for Methicillin Resistant S. Aureus "STOP MRSA"

Trial phase: 
Phase III
Recruitment status: 
Recruiting

The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 1,590 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.

Background information
Trial ID: 
NCT00729937
Other unique IDs: 
07-0040
Official title: 

Strategies Using Off-Patent Antibiotics for Methicillin-Resistant Staphylococcus Aureus ("STOP MRSA") - A Phase IIB, Multi-Center, Randomized, Double-Blind, Clinical Trial

Detailed description: 

This is a multi-center, randomized, double-blind clinical trial in which patients will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs.

Number to be enrolled: 
1590 patients

Bone Mineral Density Substudy - An Ancillary Study to MTN-003

Recruitment status: 
Not yet recruiting

The MTN-003 HIV prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (TDF) and emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) - oral, FDA-approved, anti-HIV drugs. The purpose of this study is to determine if taking daily TDF and FTC/TDF as a part of the study MTN-003 has an effect on bone mineral density (BMD).

Background information
Trial ID: 
NCT00729573
Other unique IDs: 
MTN-003B
Official title: 

Phase 2B Safety and Effectiveness Study of Tenofovir 1% Gel, Tenofovir Disproxil Fumarate Tablet and Emtricitabine/Tenofovir Disoproxil Fumarate Tablet for the Prevention of HIV Infection in Women

Detailed description: 

The effect of tenofovir on bone mineral density (BMD) has not yet been studied and is of potential concern. The purpose of this study is to determine the changes in BMD among individuals receiving TDF and FTC/TDF compared with a placebo. This substudy will enroll individuals currently participating in MTN-003. The expected duration of participation for each participant is approximately 33 months. Study treatment will be provided by MTN-003. Study treatment will not be provided by this substudy. Study visits will occur every 6 months after enrollment.

Number to be enrolled: 
300 patients

Linezolid to Treat Extensively-Drug Resistant Tuberculosis

This study, conducted in Masan, South Korea, will investigate the effectiveness of linezolid (LZD) in treating patients with extensively drug resistant tuberculosis (XDR TB). Because regular medicines do not work well against XDR TB, many more people die from it than from regular TB, which can be successfully treated by taking TB medication for 6 months. Linezolid has been used to treat other kinds of infections, but has not been well studied for TB. This study will look at the side effects and effectiveness of prolonged treatment with linezolid at two different doses. People 20 years of age and older who have XDR TB may be eligible for this 3-year study. Participants undergo the following tests and procedures:

  • LZD treatment: Patients are randomly assigned to one of two study groups. Group 1 patients are observed for 2 months before starting LZD, while group 2 patients begin taking LZD right away. Both groups begin with a 600 mg daily dose of LZD. After patients stop coughing up TB germs (or after 4 months on LZD) they are randomly assigned either to continue taking 600 mg of LZD for the rest of the study or to take a decreased dose of 300 mg. In addition to LZD, patients continue to take their currently prescribed TB medications.
  • Medical history.
  • Physical examinations each month during treatment.
  • Sputum collections once a week or more until 3 weeks after the patient is no longer contagious.
  • Blood draws every week for 16 to 24 weeks and then once a month.
  • Urine collections at several time points.
  • Nerve and eye examinations before starting treatment and then monthly to look for possible LZD side effects.
  • CT scans of the lungs three to four times the first year and once more later in the study. For this test the patient lies on a table within the doughnut-shaped CT scanner while special X-ray pictures are taken.

Patients who participate in a substudy will have PET scans instead of the CT scans. For this test, the patient is given an injection into a vein of a radioactive chemical that can be detected by a special camera and viewed on a screen. The patient lies on a table within the doughnut-shaped scanner while pictures are taken.

Background information
Other unique IDs: 
999908167
08-I-N167

Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose of this study is to determine the immune response to a yellow fever vaccine in adults with AD.

Background information
Other unique IDs: 
DAIT ADVN YF 08
HHSN266200400029C

Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine

In the 20th century, influenza pandemics occurred in 1918, 1957, and 1968, and were associated with significant morbidity and mortality. It is estimated that, in the United States alone, the next influenza pandemic could cause approximately 200,000 deaths and 750,000 hospitalizations. Thus, the development of a vaccine against potential influenza strains has become a priority. The purpose of this study is to determine the safety and immune response to an H2N2 influenza vaccine candidate.

Background information
Other unique IDs: 
CIR 247

Cause of Unexplained Anaphylaxis

This study will explore the possible cause of unexplained, or idiopathic, anaphylaxis. Anaphylaxis is a rapid, life-threatening, severe reaction that occurs suddenly after contact with an allergy-causing substance, usually a particular food, drug or stinging insect. The allergen triggers mast cells to release several substances, including histamine. Histamine is responsible for many of the symptoms that may occur, such as flushing, hives, swelling of the palms and soles or tongue and vocal cords, nasal congestion, itching and tearing of the eyes, shortness of breath and wheezing, stomach pain, vomiting, low blood pressure, loss of consciousness, shock, and, rarely, death. Severe episodes of anaphylaxis are treated with epinephrine (adrenaline), followed by oral antihistamines and steroids. In more than half of cases of anaphylaxis, a clear cause is not identified. These cases are called idiopathic anaphylaxis. There is no cure or long-term preventive therapy for patients with recurrent episodes of idiopathic anaphylaxis. People between 18 and 55 years of age who have idiopathic anaphylaxis episodes at least 6 times a year (with at least one episode every 3 months) may be eligible for this study. Participants are evaluated at the NIH Clinical Center with the following tests and procedures:

  • Medical history, physical examination and blood tests.
  • Bone marrow biopsy. For this test, the skin over the hipbone and the outer surface of the hipbone itself are numbed with local anesthesia. Then, a needle is inserted into the hipbone and a small amount of bone marrow is drawn into a syringe. The needle also cuts a small core of bone marrow, which is removed for analysis.
  • Other tests that may be needed for evaluation of the patient's condition.

Background information
Other unique IDs: 
080184
08-I-0184

Differences in Malaria Infection Levels in HIV-Infected Infants and Children Receiving PI- and NNRTI-Based HAART

Trial phase: 
Phase 0
Recruitment status: 
Not yet recruiting

More than 1.5 million deaths of African children under 5 years of age have been due to Plasmodium falciparum malaria. When HIV and malaria are present as coinfections, they enhance each other's progression. The primary purpose of this study is to compare the malarial infection levels in HIV-infected infants and children receiving protease inhibitor (PI)- or non-nucleotide reverse transcriptase inhibitor (NNRTI)-based highly active antiretroviral therapy (HAART).

Background information
Trial ID: 
NCT00719602
Other unique IDs: 
IMPAACT P1068s
PACTG P1068s
Official title: 

P1060 Substudy Comparing Differences in Malaria Parasitemia by Real Time Quantitative PCR in HIV-Infected Infants and Children on PI-Based HAART Versus NNRTI-Based HAART

Detailed description: 

The World Health Organization (WHO) reports 1 to 2 million malaria deaths annually, with most malaria-related deaths occurring in children. The malaria burden is compounded by the HIV epidemic, which is most prevalent in areas endemic for malaria, notably Sub-Saharan Africa where nine in ten children younger than 15 years of age are infected with HIV. The purpose of this study is to compare parasitemia levels in HIV-infected infants and children receiving PI- or NNRTI-based HAART regimens. This study will enroll a total of 140 participants, 35 from each of the 4 groups in IMPAACT P1060.

Number to be enrolled: 
140 patients

Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults

Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a new dengue virus vaccine in healthy adults.

Background information
Other unique IDs: 
CIR 252

Vitamin D3 in Systemic Lupus Erythematosus

The purpose of this study is to explore the impact of vitamin D3 on the expression of alpha interferon (IFN alpha) expression in systemic lupus erythematosus (SLE) patients with vitamin D deficiency.

Background information
Other unique IDs: 
DAIT ALE02
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