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NCT00000933 Clinical Trial

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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000933
Other study ID # CPCRA 054
Secondary ID 11607Parent Stud
Status Completed
Phase
First received
Last updated
Est. completion date July 2000

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 326
Est. completion date July 2000
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria You may be eligible for this study if you: - Are enrolled in CPCRA 048.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Partners in Research / New Mexico Albuquerque New Mexico
United States AIDS Research Consortium of Atlanta Atlanta Georgia
United States Southern New Jersey AIDS Cln Trials / Dept of Med Camden New Jersey
United States AIDS Research Alliance - Chicago Chicago Illinois
United States Denver CPCRA / Denver Public Hlth Denver Colorado
United States Henry Ford Hosp Detroit Michigan
United States Wayne State Univ - WSU/DMC / Univ Hlth Ctr Detroit Michigan
United States Louisiana Comm AIDS Rsch Prog / Tulane Univ Med New Orleans Louisiana
United States Harlem AIDS Treatment Grp / Harlem Hosp Ctr New York New York
United States North Jersey Community Research Initiative Newark New Jersey
United States Philadelphia FIGHT Philadelphia Pennsylvania
United States The Research and Education Group Portland Oregon
United States Richmond AIDS Consortium / Div of Infect Diseases Richmond Virginia
United States Community Consortium / UCSF San Francisco California
United States Washington Reg AIDS Prog / Dept of Infect Dis Washington District of Columbia

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)

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