TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
TBTC Study 27: An Evaluation of the Activity and Tolerability of Moxifloxacin During the First Two Months of Treatment for Pulmonary Tuberculosis--A Double-Blind, Randomized, Multicenter Study by the Tuberculosis Trials Consortium
1 other identifier
interventional
350
4 countries
23
Brief Summary
This study is a placebo-controlled factorial study, randomized to study drug (moxifloxacin vs. ethambutol) and treatment frequency (daily vs. thrice weekly after an initial two weeks of daily therapy) during the first two months of standard treatment (with isoniazid, rifampin, and pyrazinamide) for sputum smear-positive pulmonary tuberculosis.
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 2003
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, 2003
CompletedFirst Submitted
Initial submission to the registry
August 30, 2005
CompletedFirst Posted
Study publicly available on registry
September 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMarch 19, 2007
March 1, 2007
August 30, 2005
March 16, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Two-month culture conversion
Serious Adverse Event
Interventions
Eligibility Criteria
You may qualify if:
- Suspected pulmonary tuberculosis with acid-fast bacilli in a stained sputum smear - patients whose sputum cultures do not grow M. tuberculosis and those having an M. tuberculosis isolate resistant to rifampin will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
- Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment
- or fewer days of tuberculosis therapy in the 6 months preceding enrollment
- Age \> 18 years
- Karnofsky score of at least 60
- Signed informed consent
- Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual sex.
- Laboratory parameters within 14 days of enrollment:
- Serum amino aspartate transferase (AST) activity less than 3 times the upper limit of normal
- Serum total bilirubin level less than 2.5 times upper limit of normal
- Serum creatinine level less than 2 times upper limit of normal
- Hemoglobin level of at least 7.0 g/dL
- Platelet count of at least 50,000/mm3
- Serum potassium \> 3.0 meq/L
- Negative pregnancy test (for women of childbearing potential)
You may not qualify if:
- Breast-feeding
- Known intolerance to any of the study drugs
- Known allergy to any fluoroquinolone antibiotic
- Current or planned therapy during the first 2 months of tuberculosis treatment using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy)
- Current or planned antiretroviral therapy during the first 2 months of tuberculosis treatment
- History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the first 2 months of tuberculosis treatment.
- Pulmonary silicosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
University of Southern California Medical Center
Los Angeles, California, 90033, United States
University of California at San Diego
San Diego, California, 92103, United States
University of California, San Francisco
San Francisco, California, 94110, United States
Denver Public Health Department
Denver, Colorado, 80204, United States
Washington DC Veterans Administration Medical Center
Washington D.C., District of Columbia, 20422, United States
Emory University School of Medicine
Atlanta, Georgia, 30303, United States
Hines Vetrans Administration Medical Center
Hines, Illinois, 60141, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
New Jersey School of Medicine
Newark, New Jersey, 07107, United States
New York University School of Medicine
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Harlem Hospital Center
New York, New York, 10037, United States
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, 37232, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76104, United States
Houston Veterans Administration Medical Center
Houston, Texas, 77030, United States
Audie L Murphy Memorial Veterans Administration Medical Center
San Antonio, Texas, 78284, United States
Seattle-King County Health Department
Seattle, Washington, 98104, United States
University of British Columbia
Vancouver, British Columbia, V5Z 1L8, Canada
University of Manitoba
Winnipeg, Manitoba, R3A 1R8, Canada
Montreal Chest Institute
Montreal, Quebec, H2X 2P4, Canada
Nelson R Mandela School of Medicine
Durban, KwaZulu-Natal, South Africa
Makerere University Medical School
Kampala, Uganda
Related Publications (2)
Burman WJ, Goldberg S, Johnson JL, Muzanye G, Engle M, Mosher AW, Choudhri S, Daley CL, Munsiff SS, Zhao Z, Vernon A, Chaisson RE. Moxifloxacin versus ethambutol in the first 2 months of treatment for pulmonary tuberculosis. Am J Respir Crit Care Med. 2006 Aug 1;174(3):331-8. doi: 10.1164/rccm.200603-360OC. Epub 2006 May 4.
PMID: 16675781RESULTZhang N, Savic RM, Boeree MJ, Peloquin CA, Weiner M, Heinrich N, Bliven-Sizemore E, Phillips PPJ, Hoelscher M, Whitworth W, Morlock G, Posey J, Stout JE, Mac Kenzie W, Aarnoutse R, Dooley KE; Tuberculosis Trials Consortium (TBTC) and Pan African Consortium for the Evaluation of Antituberculosis Antibiotics (PanACEA) Networks. Optimising pyrazinamide for the treatment of tuberculosis. Eur Respir J. 2021 Jul 20;58(1):2002013. doi: 10.1183/13993003.02013-2020. Print 2021 Jul.
PMID: 33542052DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Burman, MD
Denver Public Health Department
- PRINCIPAL INVESTIGATOR
Richard E Chaisson, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
Study Record Dates
First Submitted
August 30, 2005
First Posted
September 1, 2005
Study Start
July 1, 2003
Study Completion
December 1, 2005
Last Updated
March 19, 2007
Record last verified: 2007-03