TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00140309
First received: August 30, 2005
Last updated: March 16, 2007
Last verified: March 2007

August 30, 2005
March 16, 2007
July 2003
Not Provided
  • Two-month culture conversion
  • Serious Adverse Event
Same as current
Complete list of historical versions of study NCT00140309 on ClinicalTrials.gov Archive Site
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Not Provided
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TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Tuberculosis, Pulmonary
Drug: moxifloxacin (with isoniazid, rifampin, pyrazinamide)
Not Provided
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. Epub 2006 May 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
December 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   South Africa,   Uganda
 
NCT00140309
CDC-NCHSTP-3716
Yes
Not Provided
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: William Burman, MD Denver Public Health Department
Principal Investigator: Richard E Chaisson, MD Johns Hopkins University
Centers for Disease Control and Prevention
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP