TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tuberculosis, Pulmonary
Intervention: moxifloxacin (with isoniazid, rifampin, pyrazinamide) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): William Burman, MD, Principal Investigator, Affiliation: Denver Public Health Department Richard E Chaisson, MD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Two-month culture conversionSerious Adverse Event
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. 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
3. 7 or fewer days of tuberculosis therapy in the 6 months preceding enrollment
4. Age > 18 years
5. Karnofsky score of at least 60
6. Signed informed consent
7. Women with child-bearing potential must agree to practice an adequate (barrier)
method of birth control or to abstain from heterosexual sex.
8. 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:
1. Breast-feeding
2. Known intolerance to any of the study drugs
3. Known allergy to any fluoroquinolone antibiotic
4. 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)
5. Current or planned antiretroviral therapy during the first 2 months of tuberculosis
treatment
6. 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.
7. Pulmonary silicosis
Locations and Contacts
Makerere University Medical School, Kampala, Uganda
University of British Columbia, Vancouver, British Columbia V5Z 1L8, Canada
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 DC, 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
Nelson R Mandela School of Medicine, Durban, KwaZulu Natal, South Africa
University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada
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
Columbia University, New York, New York 10032, United States
Harlem Hospital Center, New York, New York 10037, United States
New York University School of Medicine, New York, New York 10016, United States
Montreal Chest Institute, Montreal, Quebec H2X 2P4, Canada
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
Additional Information
Tuberculosis Trials Consortium (TBTC) web page
Starting date: July 2003
Last updated: March 16, 2007
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