Mycobacterium Avium-intracellulare InfectionNCT00000933
Effects of MAC Preventive Therapy on Disease-Causing Bacteria in HIV-Infected Patients: A Substudy of CPCRA 048
An observational study of Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection, HIV Infections, Pneumococcal Infections
- How many people
- 326 participants
- Where
- 15 sitesUnited States
- Study dates
- Start not givento Jul 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are enrolled in CPCRA 048.
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Partners in Research / New Mexico
Albuquerque, New Mexico, 87131
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, 08103
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Denver CPCRA / Denver Public Hlth
Denver, Colorado, 80204
Wayne State Univ - WSU/DMC / Univ Hlth Ctr
Detroit, Michigan, 48201
Henry Ford Hosp
Detroit, Michigan, 48202
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, 70112
Harlem AIDS Treatment Grp / Harlem Hosp Ctr
New York, New York, 10037
North Jersey Community Research Initiative
Newark, New Jersey, 07103
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107
The Research and Education Group
Portland, Oregon, 97210
Richmond AIDS Consortium / Div of Infect Diseases
Richmond, Virginia, 23298
Community Consortium / UCSF
San Francisco, California, 94110
Washington Reg AIDS Prog / Dept of Infect Dis
Washington D.C., District of Columbia, 20422
About this study
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)
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.
Read the 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.
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Antibiotics, Macrolide, Azithromycin, Drug Administration Schedule, Drug Resistance, Microbial, Carrier State, Streptococcus pneumoniae
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, Pneumococcal Infections, AIDS-Related Opportunistic Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionJul 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium Avium-intracellulare InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 326 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- El-Sadr W, Study chairBurman W, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000933
- Sponsor's protocol ID
- CPCRA 054
- Other IDs
- 11607, Parent Study CPCRA 048
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
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 at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00000933
- Acronym / sponsor ID
- CPCRA 054
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, Antibiotics, Macrolide, Azithromycin, Drug Administration Schedule, Drug Resistance, Microbial, Carrier State, Streptococcus pneumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2000 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are enrolled in CPCRA 048.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- BackgroundEl-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
El-Sadr W study chair
Burman W study chair
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000933, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.