Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000933
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
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
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11607 | REGISTRY | None | None |
| Parent Study CPCRA 048 | Registry Identifier | DAIDS ES | None |