National Institute of Allergy and Infectious Diseases (NIAID)

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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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