A Registry of Tuberculosis Cases in the CPCRA

NCT ID: NCT00000785

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1509 participants

Study Classification

OBSERVATIONAL

Study Start Date

1992-08-31

Study Completion Date

1994-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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HIV Infections Tuberculosis

Keywords

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Tuberculosis Mycobacterium tuberculosis AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Drug Resistance, Microbial

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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A

All eligible CPCRA subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Patients must meet the following criteria:

* CPCRA patients with confirmed pulmonary or extrapulmonary TB. Confirmed clinical TB requires a positive culture for Mycobacterium tuberculosis.

NOTE:

* There is no requirement that patients have HIV infection.
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Gordin

Role: STUDY_CHAIR

Locations

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Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States

Site Status

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States

Site Status

AIDS Research Alliance - Chicago

Chicago, Illinois, United States

Site Status

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States

Site Status

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, United States

Site Status

Henry Ford Hosp

Detroit, Michigan, United States

Site Status

North Jersey Community Research Initiative

Newark, New Jersey, United States

Site Status

Addiction Research and Treatment Corp

Brooklyn, New York, United States

Site Status

Clinical Directors Network of Region II

New York, New York, United States

Site Status

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, United States

Site Status

Bronx Lebanon Hosp Ctr

The Bronx, New York, United States

Site Status

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States

Site Status

Richmond AIDS Consortium

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Gordin FM, Nelson ET, Matts JP, Cohn DL, Ernst J, Benator D, Besch CL, Crane LR, Sampson JH, Bragg PS, El-Sadr W. The impact of human immunodeficiency virus infection on drug-resistant tuberculosis. Am J Respir Crit Care Med. 1996 Nov;154(5):1478-83. doi: 10.1164/ajrccm.154.5.8912768.

Reference Type BACKGROUND
PMID: 8912768 (View on PubMed)

Other Identifiers

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11568

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPCRA 017

Identifier Type: -

Identifier Source: org_study_id