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

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

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:

  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

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
Two-month culture conversion
Serious Adverse Event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

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

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

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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