A Registry of Tuberculosis Cases in the CPCRA

National Institute of Allergy and Infectious Diseases (NIAID)

Status

Completed

Conditions

Tuberculosis

HIV Infections

Study type

Observational

Funder types

NIH

Identifiers

NCT00000785

CPCRA 017

11568 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,509 patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients must meet the following criteria: