TBTC Study 25: Study of the Tolerability of Higher Doses of Rifapentine in the Treatment of Tuberculosis
TBTC Study 25:A Prospective, Randomized, Double-Blind Study of the Tolerability of Higher Doses of Rifapentine
3 other identifiers
interventional
150
2 countries
23
Brief Summary
Randomized, double-blind study of the tolerability of three different doses of rifapentine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 1999
Typical duration for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedFirst Submitted
Initial submission to the registry
September 6, 2001
CompletedFirst Posted
Study publicly available on registry
September 10, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedSeptember 13, 2005
September 1, 2005
September 6, 2001
September 9, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients who fail to complete therapy in each of the dosing groups
Secondary Outcomes (3)
1. Rate of serious adverse events in each of the dosing groups
2. Rate of total adverse events in each of the groups
3. Rate of relapse in patients with positive sputum culture at 2 months, in each of the groups
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (23)
Central Arkansas Veterans Health System
Little Rock, Arkansas, 72205, United States
LA County/USC Medical Center
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94110, United States
Denver Department of Public Health and Hospitals
Denver, Colorado, 80204, United States
Washington, D.C. VAMC
Washington D.C., District of Columbia, 20422, United States
Chicago VA Medical Center (Lakeside)
Chicago, Illinois, 60611, United States
Hines VA Medical Center
Hines, Illinois, 60141, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287-0003, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
New Jersey Medical School
Newark, New Jersey, 07107-3001, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University/Presbyterian Medical Center
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Duke University Medical Center
Durham, North Carolina, 34222, United States
Nashville VA Medical Center
Nashville, Tennessee, 37212-2637, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107-2699, United States
Thomas Street Clinic
Houston, Texas, 77009, United States
Audi L. Murphy VA Hospital
San Antonio, Texas, 78284, United States
Seattle King County Health Department
Seattle, Washington, 98104, United States
University of British Columbia
Vancouver, British Columbia, Canada V5Z 4R4, Canada
University of Manitoba
Winnipeg, Manitoba, CANADA R3A 1R8, Canada
Montreal Chest Institute McGill University
Montreal, Quebec, H2X 2P4Pq Canada, Canada
Related Publications (1)
Bock NN, Sterling TR, Hamilton CD, Pachucki C, Wang YC, Conwell DS, Mosher A, Samuels M, Vernon A; Tuberculosis Trials Consortium, Centers for Disease Control and Prevention, Atlanta, Georgia. A prospective, randomized, double-blind study of the tolerability of rifapentine 600, 900, and 1,200 mg plus isoniazid in the continuation phase of tuberculosis treatment. Am J Respir Crit Care Med. 2002 Jun 1;165(11):1526-30. doi: 10.1164/rccm.200201-047OC.
PMID: 12045127RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Naomi Bock, MD
Centers for Disease Control & Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
September 6, 2001
First Posted
September 10, 2001
Study Start
July 1, 1999
Study Completion
February 1, 2003
Last Updated
September 13, 2005
Record last verified: 2005-09