TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment - Full Text View

Sponsor:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00140309

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 II

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:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Isoniazid Rifampin Pyrazinamide Moxifloxacin Moxifloxacin hydrochloride Ftivazide

U.S. FDA Resources

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:

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.
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
7 or fewer days of tuberculosis therapy in the 6 months preceding enrollment
Age > 18 years
Karnofsky score of at least 60
Signed informed consent
Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual sex.
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:

Breast-feeding
Known intolerance to any of the study drugs
Known allergy to any fluoroquinolone antibiotic
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)
Current or planned antiretroviral therapy during the first 2 months of tuberculosis treatment
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.
Pulmonary silicosis

Contacts and Locations

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

Show 23 Study Locations

Sponsors and Collaborators

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

More Information

Additional Information:

Tuberculosis Trials Consortium (TBTC) web page This link exits the ClinicalTrials.gov site

Publications:

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.

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
Isoniazid
Pyrazinamide
Rifampin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Fatty Acid Synthesis Inhibitors

Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Lipid Regulating Agents
Antibiotics, Antitubercular
Enzyme Inhibitors
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Contraceptives, Oral, Combined
Contraceptives, Oral

ClinicalTrials.gov processed this record on February 09, 2012