TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140309
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : March 19, 2007
Information provided by:
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Tuberculosis, Pulmonary Drug: moxifloxacin (with isoniazid, rifampin, pyrazinamide) Phase 2

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  (Clinical Trial)
Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: 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 Start Date : July 2003
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Primary Outcome Measures :
  1. Two-month culture conversion
  2. Serious Adverse Event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140309

  Hide Study Locations
United States, California
University of Southern California Medical Center
Los Angeles, California, United States, 90033
University of California at San Diego
San Diego, California, United States, 92103
University of California, San Francisco
San Francisco, California, United States, 94110
United States, Colorado
Denver Public Health Department
Denver, Colorado, United States, 80204
United States, District of Columbia
Washington DC Veterans Administration Medical Center
Washington DC, District of Columbia, United States, 20422
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
United States, Illinois
Hines Vetrans Administration Medical Center
Hines, Illinois, United States, 60141
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
New Jersey School of Medicine
Newark, New Jersey, United States, 07107
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Columbia University
New York, New York, United States, 10032
Harlem Hospital Center
New York, New York, United States, 10037
United States, Tennessee
Veterans Administration Tennessee Valley Health Care System
Nashville, Tennessee, United States, 37232
United States, Texas
University of North Texas Health Science Center
Fort Worth, Texas, United States, 76104
Houston Veterans Administration Medical Center
Houston, Texas, United States, 77030
Audie L Murphy Memorial Veterans Administration Medical Center
San Antonio, Texas, United States, 78284
United States, Washington
Seattle-King County Health Department
Seattle, Washington, United States, 98104
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3A 1R8
Canada, Quebec
Montreal Chest Institute
Montreal, Quebec, Canada, H2X 2P4
South Africa
Nelson R Mandela School of Medicine
Durban, KwaZulu Natal, South Africa
Makerere University Medical School
Kampala, Uganda
Sponsors and Collaborators
Centers for Disease Control and Prevention
Principal Investigator: William Burman, MD Denver Public Health Department
Principal Investigator: Richard E Chaisson, MD Johns Hopkins University

Additional Information:
Publications of Results: Identifier: NCT00140309     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3716
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: March 19, 2007
Last Verified: March 2007

Keywords provided by Centers for Disease Control and Prevention:
Pulmonary Tuberculosis
Pulmonary TB

Additional relevant MeSH terms:
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
Antibiotics, Antitubercular