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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000933

Collaborator

(none)

326

Enrollment

Locations

21.7

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellulare Infection HIV Infections Pneumococcal Infections

Detailed 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.

Study Design

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)

Actual Study Completion Date :

Jul 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

You may be eligible for this study if you:

Are enrolled in CPCRA 048.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium / UCSF	San Francisco	California	United States	94110
2	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	80204
3	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia	United States	20422
4	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
5	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
6	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
7	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan	United States	48201
8	Henry Ford Hosp	Detroit	Michigan	United States	48202
9	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey	United States	08103
10	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
11	Partners in Research / New Mexico	Albuquerque	New Mexico	United States	87131
12	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York	United States	10037
13	The Research and Education Group	Portland	Oregon	United States	97210
14	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
15	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia	United States	23298