Clinical Trial: Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048

This study is no longer recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

Some people who have taken azithromycin to prevent MAC (Mycobacterium avium Complex, a bacterial infection common in HIV-infected persons) have been found to carry antibiotic-resistant bacteria (germs that grow despite the presence of drugs used to kill them). The purpose of this study is to see if people who take azithromycin carry more antibiotic-resistant bacteria than people who have chosen to delay MAC preventive therapy. When bacteria like Streptococcus (a type of bacteria that causes pneumonia and meningitis) are frequently exposed to antibiotics, the bacteria can become resistant to the drugs. MAC preventive therapy uses antibiotics, but this can make it difficult to treat other infections caused by bacteria that have become resistant in HIV-infected persons. If MAC preventive therapy is delayed, Streptococcus in the body may be less likely to develop resistance. Therefore, if the patient does get a Streptococcus infection, it will be easier to treat because it is not resistant to the antibiotics.

Condition
Mycobacterium avium-intracellulare Infection
HIV Infections
Pneumococcal Infections

MedlinePlus related topics:  AIDS;   Bacterial Infections;   Streptococcal Infections;   Throat Disorders

Study Type: Observational
Study Design: Natural History

Official Title: Effects of Prophylaxis for Disseminated Mycobacterium Avium Complex (MAC) Disease with Azithromycin Versus Deferred Prophylaxis on Carriage of Antibiotic-Resistant Streptococcus pneumoniae: A Substudy of the CR-MAC Protocol (CPCRA 048)

Further Study Details: 

Expected Total Enrollment:  450

Streptococcus pneumoniae is a leading cause of bacteremia, pneumonia, meningitis, and otitis media in the United States. Prior to 1987, this organism was uniformly susceptible to penicillin; since then, however, increasing numbers of isolates resistant to penicillin, as well as to other common antibiotics, have been identified. Frequent exposure to antibiotics has been documented as an important risk factor for the emergence of resistant organisms in HIV-infected patients, who are more likely than uninfected people to be colonized with antibiotic-resistant strains of S. pneumoniae. This substudy is the first to examine the effects of withdrawing or delaying the initiation of prophylaxis (in this case, MAC prophylaxis) on the prevalence of antibiotic-resistant pneumococci in a prospective manner.

Study participants are a subset of those enrolled in the CR-MAC Protocol (CPCRA 048). Oropharyngeal swabs are taken at baseline and 4 months after randomization, and are used to isolate S. pneumoniae in culture. These isolates are tested for susceptibility to macrolides, penicillin, cephalosporins, quinolones, and TMP-SMX. The rates of pneumococcal colonization at baseline and 4 months after randomization are determined and used to estimate the impact of deferring MAC prophylaxis on carriage of antibiotic-resistant S. pneumoniae.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

You may be eligible for this study if you:

  • Are enrolled in CPCRA 048.

Location Information


California
      Community Consortium / UCSF, San Francisco,  California,  94110,  United States

Colorado
      Denver CPCRA / Denver Public Hlth, Denver,  Colorado,  802044507,  United States

District of Columbia
      Washington Reg AIDS Prog / Dept of Infect Dis, Washington,  District of Columbia,  20422,  United States

Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  303081962,  United States

Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States

Louisiana
      Louisiana Comm AIDS Rsch Prog / Tulane Univ Med, New Orleans,  Louisiana,  70112,  United States

Michigan
      Henry Ford Hosp, Detroit,  Michigan,  48202,  United States

      Wayne State Univ - WSU/DMC / Univ Hlth Ctr, Detroit,  Michigan,  48201,  United States

New Jersey
      North Jersey Community Research Initiative, Newark,  New Jersey,  071032842,  United States

      Southern New Jersey AIDS Cln Trials / Dept of Med, Camden,  New Jersey,  08103,  United States

New Mexico
      Partners in Research / New Mexico, Albuquerque,  New Mexico,  87131,  United States

New York
      Harlem AIDS Treatment Grp / Harlem Hosp Ctr, New York,  New York,  10037,  United States

Oregon
      The Research and Education Group, Portland,  Oregon,  97210,  United States

Pennsylvania
      Philadelphia FIGHT, Philadelphia,  Pennsylvania,  19107,  United States

Virginia
      Richmond AIDS Consortium / Div of Infect Diseases, Richmond,  Virginia,  232980049,  United States

Study chairs or principal investigators

El-Sadr W,  Study Chair
Burman W,  Study Chair

More Information

Haga clic aquí para ver información sobre este ensayo clínico en español.

Publications

El-Sadr WM, Manneheimer S, Grant L, Matts J. Use of PCP and MAC prophylaxis among eligible patients with and without CD4+ rebound. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29 (abstract no 129)

Study ID Numbers:  CPCRA 054; Parent Study CPCRA 048
Record last reviewed:  August 2004
Last Updated:  April 7, 2005
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00000933
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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