Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000785
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
1999-11-02
Brief Title:
A Registry of Tuberculosis Cases in the CPCRA
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Registry of Tuberculosis Cases in the CPCRA
Status:
COMPLETED
Status Verified Date:
2013-09
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:
PRIMARY To estimate the proportion of tuberculosis patients in the CPCRA who have drug-resistant tuberculosis TB and to describe the patterns of drug resistance
SECONDARY To compare drug resistance data on the Mycobacterium tuberculosis isolates of HIV-infected patients to those of HIV-uninfected patients who are being followed in the CPCRA To assess the relationship of resistance data with geographic demographic and HIV and TB risk factor information
Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic The total number of CPCRA patients who will develop or who have experienced confirmed TB is unknown It is critical to determine the depth and breadth of the current problem of drug-resistant TB
SECONDARY To compare drug resistance data on the Mycobacterium tuberculosis isolates of HIV-infected patients to those of HIV-uninfected patients who are being followed in the CPCRA To assess the relationship of resistance data with geographic demographic and HIV and TB risk factor information
Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic The total number of CPCRA patients who will develop or who have experienced confirmed TB is unknown It is critical to determine the depth and breadth of the current problem of drug-resistant TB
Detailed Description:
Geographic areas and demographic subgroups affected by the TB epidemic appear to be congruent and associated with the concurrent HIV epidemic The total number of CPCRA patients who will develop or who have experienced confirmed TB is unknown It is critical to determine the depth and breadth of the current problem of drug-resistant TB
For both retrospective and prospective components of the study demographic geographic HIV and TB risk factor information will be collected on CPCRA patients with confirmed pulmonary or extrapulmonary TB Mycobacterial culture results will be recorded Retrospective data will be collected on CPCRA patients with confirmed tuberculosis who have been diagnosed since January 1992 until the time of site registration Prospective data will be collected on CPCRA patients with confirmed tuberculosis diagnosed during the period of 1 to 2 years following site registration
For both retrospective and prospective components of the study demographic geographic HIV and TB risk factor information will be collected on CPCRA patients with confirmed pulmonary or extrapulmonary TB Mycobacterial culture results will be recorded Retrospective data will be collected on CPCRA patients with confirmed tuberculosis who have been diagnosed since January 1992 until the time of site registration Prospective data will be collected on CPCRA patients with confirmed tuberculosis diagnosed during the period of 1 to 2 years following site registration
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 |
|---|---|---|---|
| 11568 | REGISTRY | DAIDS ES | None |