Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048
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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 |
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Mycobacterium Avium-intracellulare Infection HIV Infections Pneumococcal Infections |
Study Type: | Observational |
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) |
Estimated Enrollment: | 326 |
Study Completion Date: | July 2000 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
You may be eligible for this study if you:
- Are enrolled in CPCRA 048.
United States, California | |
Community Consortium / UCSF | |
San Francisco, California, United States, 94110 | |
United States, Colorado | |
Denver CPCRA / Denver Public Hlth | |
Denver, Colorado, United States, 802044507 | |
United States, District of Columbia | |
Washington Reg AIDS Prog / Dept of Infect Dis | |
Washington, District of Columbia, United States, 20422 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 303081962 | |
United States, Illinois | |
AIDS Research Alliance - Chicago | |
Chicago, Illinois, United States, 60657 | |
United States, Louisiana | |
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
New Orleans, Louisiana, United States, 70112 | |
United States, Michigan | |
Henry Ford Hosp | |
Detroit, Michigan, United States, 48202 | |
Wayne State Univ - WSU/DMC / Univ Hlth Ctr | |
Detroit, Michigan, United States, 48201 | |
United States, New Jersey | |
Southern New Jersey AIDS Cln Trials / Dept of Med | |
Camden, New Jersey, United States, 08103 | |
North Jersey Community Research Initiative | |
Newark, New Jersey, United States, 071032842 | |
United States, New Mexico | |
Partners in Research / New Mexico | |
Albuquerque, New Mexico, United States, 87131 | |
United States, New York | |
Harlem AIDS Treatment Grp / Harlem Hosp Ctr | |
New York, New York, United States, 10037 | |
United States, Oregon | |
The Research and Education Group | |
Portland, Oregon, United States, 97210 | |
United States, Pennsylvania | |
Philadelphia FIGHT | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, Virginia | |
Richmond AIDS Consortium / Div of Infect Diseases | |
Richmond, Virginia, United States, 232980049 |
Study Chair: | El-Sadr W | |
Study Chair: | Burman W |
Additional Information:
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000933 History of Changes |
Other Study ID Numbers: | CPCRA 054, 11607, Parent Study CPCRA 048 |
Study First Received: | November 2, 1999 |
Last Updated: | May 17, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections Mycobacterium avium-intracellulare Infection Antibiotics, Macrolide Azithromycin |
Drug Administration Schedule Drug Resistance, Microbial Carrier State Streptococcus pneumoniae |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Mycobacterium Infections Mycobacterium avium-intracellulare Infection Pneumococcal Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Mycobacterium Infections, Atypical Streptococcal Infections Anti-Bacterial Agents Azithromycin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013