Advertisement

Topics

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

2014-07-24 14:36:39 | BioPortfolio

Summary

This study compares 2 different treatments administered to try to prevent serious bacterial infections (such as pneumonia) in HIV-positive children. A combination of drugs (azithromycin plus atovaquone) will be compared to sulfamethoxazole-trimethoprim (SMX/TMP) alone. This study also evaluates the long-term safety and tolerance of these different drugs.

SMX/TMP is a commonly prescribed drug for the prevention of bacterial infections. However, the combination of azithromycin and atovaquone may be safer and more effective than SMX/TMP. This study compares the 2 treatments.

Description

Although SMX/TMP remains the drug of choice for PCP prophylaxis, drug sensitivity may limit its use. Atovaquone has demonstrated greater safety than SMX/TMP and thus is suitable as a candidate drug for treatment and prophylaxis of PCP. Azithromycin, with a broad anti-microbial spectrum (including mycoplasma and atypical mycoplasma), is an attractive prophylactic agent for use in children with HIV infection, due to its relative safety and once-daily dosing regimen. Therefore, the combination of atovaquone and azithromycin may offer broader antimicrobial coverage and greater safety than SMX/TMP.

Patients are randomized to receive either SMX/TMP or combination micronized atovaquone/azithromycin. Crossover to the alternative regimen may occur if serious toxicity is observed. Patients are monitored for occurrence of serious bacterial infections or PCP breakthrough, and when a serious bacterial infection occurs, patients are crossed over to the alternative regimen. Treatment continues until 2 years after the last patient is enrolled. The first 30 patients will undergo a pharmacokinetic profile. Patients are followed every 4 weeks for the first 4 months, then every 8 weeks thereafter. [AS PER AMENDMENT 05/28/99: This study was closed to infants and children age 19 months and older on 2/15/99; the study is now open to infants age 3 to 18 months (Stage II). Patients who are age 24 months or older at the time of Stage I closure will have end-of-study evaluations and will no longer be followed on protocol. Patients who are less than 24 months of age at the time of Stage I closure will be allowed to continue in the current version of the protocol. Enrollment for children age 3 to 18 months will continue until 50 subjects have been randomized. Because Stage II is an unblinded study, patients who are less than 24 months of age currently enrolled on Version 4.0 will have their study medication regimen unblinded and their atovaquone dose increased.]

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Conditions

Bacterial Infections

Intervention

Azithromycin, Atovaquone, Sulfamethoxazole-Trimethoprim

Location

Univ of Alabama at Birmingham - Pediatric
Birmingham
Alabama
United States
35233

Status

Completed

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:36:39-0400

Clinical Trials [1007 Associated Clinical Trials listed on BioPortfolio]

Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to d...

A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in...

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

To determine the effects of fluconazole and either rifabutin or clarithromycin, alone and in combination, on the pharmacokinetics of first sulfamethoxazole-trimethoprim and then dapsone in...

Trimethoprim-Sulfamethoxazole or Doxycycline for Skin and Soft Tissue Infections

Background: In many communities, skin and soft tissue infections (SSTI) with MRSA have become more prevalent than infections with β-lactam susceptible bacteria. This has necessitated alt...

Fluoroquinolone Associated Disability

The purpose of this study is to: 1) describe drug utilization for Fluoroquinolone(FQ), Azithromycin (AZ) and Sulfamethoxazole/Trimethoprim(ST) in the entire Truven MarketScan Commercial Cl...

PubMed Articles [6567 Associated PubMed Articles listed on BioPortfolio]

In Vitro Bactericidal Activity of Trimethoprim-Sulfamethoxazole/Colistin Combination Against Carbapenem-Resistant Klebsiella pneumoniae Clinical Isolates.

Carbapenem-resistant Klebsiella pneumoniae (CRKP) has emerged as a formidable health challenge in recent years owing to the shortage of effective antibiotics. Colistin is the last and sometimes the on...

Impact of Trimethoprim-Sulfamethoxazole Urinary Tract Infection Prophylaxis on Non-UTI Infections.

In this secondary analysis of the Randomized Intervention for Children with Vesicoureteral Reflux (RIVUR) cohort, we found that daily prophylaxis with trimethoprim-sulfamethoxazole was not associated ...

Screening method for sulfamethoxazole-trimethoprim resistant small colony variants of Staphylococcus aureus.

Sulfamethoxazole-trimethoprim (SXT) is used to treat Staphylococcus aureus infections. However, the effect of treatment with SXT is not enough, and there are patients whose treatment has to be prolong...

Increasing Clindamycin and Trimethoprim-Sulfamethoxazole Resistance in Pediatric Staphylococcus aureus Infections.

The epidemiology of Staphylococcus aureus infection in children is dynamic. We conducted a retrospective observational study on pediatric clinical cultures, performed between 2005 and 2017, that grew ...

A trimethoprim conjugate of thiomaltose has enhanced antibacterial efficacy in vivo.

Trimethoprim is one of the most widely used antibiotics in the world. However its efficacy is frequently limited by its poor water solubility and dose limiting toxicity. Prodrug strategies based on co...

Medical and Biotech [MESH] Definitions

A pyrimidine inhibitor of dihydrofolate reductase, it is an antibacterial related to PYRIMETHAMINE. The interference with folic acid metabolism may cause a depression of hematopoiesis. It is potentiated by SULFONAMIDES and the TRIMETHOPRIM-SULFAMETHOXAZOLE COMBINATION is the form most often used. It is sometimes used alone as an antimalarial. TRIMETHOPRIM RESISTANCE has been reported.

A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.

This drug combination has proved to be an effective therapeutic agent with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.

Nonsusceptibility of bacteria to the action of TRIMETHOPRIM.

Bacterial infections of the brain, spinal cord, and meninges, including infections involving the perimeningeal spaces.

More From BioPortfolio on "A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial