Back to resultsTBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
Primary Purpose
Tuberculosis, Pulmonary
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
moxifloxacin (with isoniazid, rifampin, pyrazinamide)
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring TB, Pulmonary Tuberculosis, Tuberculosis, Pulmonary TB
Eligibility Criteria
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
Sites / Locations
- University of Southern California Medical Center
- University of California at San Diego
- University of California, San Francisco
- Denver Public Health Department
- Washington DC Veterans Administration Medical Center
- Emory University School of Medicine
- Hines Vetrans Administration Medical Center
- Johns Hopkins University
- Boston University Medical Center
- New Jersey School of Medicine
- New York University School of Medicine
- Columbia University
- Harlem Hospital Center
- Veterans Administration Tennessee Valley Health Care System
- University of North Texas Health Science Center
- Houston Veterans Administration Medical Center
- Audie L Murphy Memorial Veterans Administration Medical Center
- Seattle-King County Health Department
- University of British Columbia
- University of Manitoba
- Montreal Chest Institute
- Nelson R Mandela School of Medicine
- Makerere University Medical School
Outcomes
Primary Outcome Measures
Two-month culture conversion
Serious Adverse Event
Secondary Outcome Measures
Full Information
NCT ID
NCT00140309
First Posted
August 30, 2005
Last Updated
March 16, 2007
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00140309
Brief Title
TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
Keywords
TB, Pulmonary Tuberculosis, Tuberculosis, Pulmonary TB
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
350 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
moxifloxacin (with isoniazid, rifampin, pyrazinamide)
Primary Outcome Measure Information:
Title
Two-month culture conversion
Title
Serious Adverse Event
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Burman, MD
Organizational Affiliation
Denver Public Health Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Richard E Chaisson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California at San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Denver Public Health Department
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Washington DC Veterans Administration Medical Center
City
Washington DC
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Hines Vetrans Administration Medical Center
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
New Jersey School of Medicine
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Veterans Administration Tennessee Valley Health Care System
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Houston Veterans Administration Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Audie L Murphy Memorial Veterans Administration Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Seattle-King County Health Department
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R8
Country
Canada
Facility Name
Montreal Chest Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2P4
Country
Canada
Facility Name
Nelson R Mandela School of Medicine
City
Durban
State/Province
KwaZulu Natal
Country
South Africa
Facility Name
Makerere University Medical School
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
16675781
Citation
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.
Results Reference
result
PubMed Identifier
33542052
Citation
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.
Results Reference
derived
Links:
URL
http://www.cdc.gov/nchstp/tb/tbtc/default.htm
Description
Tuberculosis Trials Consortium (TBTC) web page
Learn more about this trial
TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
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