- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140309
TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
March 16, 2007 updated by: Centers for Disease Control and Prevention
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this Phase II clinical trial is to compare the safety and microbiological activity of a moxifloxacin-containing regimen (isoniazid, rifampin, pyrazinamide, moxifloxacin [HRZMoxi]) to a control regimen (isoniazid, rifampin, pyrazinamide, ethambutol [HRZE]) in the first two months of treatment of sputum smear-positive pulmonary tuberculosis.
In addition, the study will evaluate whether intermittent administration (thrice-weekly after the first 2 weeks) of these regimens affects their tolerability and microbiological activity.
The assessment of microbiological activity will be sputum culture-conversion.
Improved sputum culture conversion after 2 months of treatment with a moxifloxacin-containing regimen would support phase 3 clinical trials of moxifloxacin in treatment regimens of less than the current 6 month standard regimens.
Study Type
Interventional
Enrollment
350
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1L8
- University of British Columbia
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1R8
- University of Manitoba
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Quebec
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Montreal, Quebec, Canada, H2X 2P4
- Montreal Chest Institute
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KwaZulu Natal
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Durban, KwaZulu Natal, South Africa
- Nelson R Mandela School of Medicine
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Kampala, Uganda
- Makerere University Medical School
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California
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Los Angeles, California, United States, 90033
- University of Southern California Medical Center
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San Diego, California, United States, 92103
- University of California at San Diego
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San Francisco, California, United States, 94110
- University of California, San Francisco
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Colorado
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Denver, Colorado, United States, 80204
- Denver Public Health Department
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District of Columbia
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Washington DC, District of Columbia, United States, 20422
- Washington DC Veterans Administration Medical Center
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University School of Medicine
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Illinois
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Hines, Illinois, United States, 60141
- Hines Vetrans Administration Medical Center
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Maryland
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Baltimore, Maryland, United States, 21231
- Johns Hopkins University
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University Medical Center
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New Jersey
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Newark, New Jersey, United States, 07107
- New Jersey School of Medicine
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New York
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New York, New York, United States, 10032
- Columbia University
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New York, New York, United States, 10016
- New York University School of Medicine
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New York, New York, United States, 10037
- Harlem Hospital Center
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Tennessee
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Nashville, Tennessee, United States, 37232
- Veterans Administration Tennessee Valley Health Care System
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Texas
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Fort Worth, Texas, United States, 76104
- University of North Texas Health Science Center
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Houston, Texas, United States, 77030
- Houston Veterans Administration Medical Center
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San Antonio, Texas, United States, 78284
- Audie L Murphy Memorial Veterans Administration Medical Center
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Washington
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Seattle, Washington, United States, 98104
- Seattle-King County Health Department
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 7 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Two-month culture conversion
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Serious Adverse Event
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: William Burman, MD, Denver Public Health Department
- Principal Investigator: Richard E Chaisson, MD, Johns Hopkins University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Zhang 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 30, 2005
First Submitted That Met QC Criteria
August 30, 2005
First Posted (Estimate)
September 1, 2005
Study Record Updates
Last Update Posted (Estimate)
March 19, 2007
Last Update Submitted That Met QC Criteria
March 16, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Hypolipidemic Agents
- Lipid Regulating Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Fatty Acid Synthesis Inhibitors
- Moxifloxacin
- Rifampin
- Isoniazid
- Pyrazinamide
Other Study ID Numbers
- CDC-NCHSTP-3716
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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