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
  Purpose

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 Intervention Phase
Tuberculosis, Pulmonary
Drug: moxifloxacin (with isoniazid, rifampin, pyrazinamide)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Two-month culture conversion
  • Serious Adverse Event

Estimated Enrollment: 350
Study Start Date: July 2003
Study Completion Date: December 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140309

  Show 23 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: William Burman, MD Denver Public Health Department
Principal Investigator: Richard E Chaisson, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00140309     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3716
Study First Received: August 30, 2005
Last Updated: March 16, 2007
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Pyrazinamide
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
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
Antitubercular Agents

ClinicalTrials.gov processed this record on September 18, 2014