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TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tuberculosis, Pulmonary

Intervention: moxifloxacin (with isoniazid, rifampin, pyrazinamide) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centers for Disease Control and Prevention

Official(s) and/or principal investigator(s):
William Burman, MD, Principal Investigator, Affiliation: Denver Public Health Department
Richard E Chaisson, MD, Principal Investigator, Affiliation: Johns Hopkins University

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

Two-month culture conversion

Serious Adverse Event

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Makerere University Medical School, Kampala, Uganda

University of British Columbia, Vancouver, British Columbia V5Z 1L8, Canada

University of Southern California Medical Center, Los Angeles, California 90033, United States

University of California at San Diego, San Diego, California 92103, United States

University of California, San Francisco, San Francisco, California 94110, United States

Denver Public Health Department, Denver, Colorado 80204, United States

Washington DC Veterans Administration Medical Center, Washington DC, District of Columbia 20422, United States

Emory University School of Medicine, Atlanta, Georgia 30303, United States

Hines Vetrans Administration Medical Center, Hines, Illinois 60141, United States

Nelson R Mandela School of Medicine, Durban, KwaZulu Natal, South Africa

University of Manitoba, Winnipeg, Manitoba R3A 1R8, Canada

Johns Hopkins University, Baltimore, Maryland 21231, United States

Boston University Medical Center, Boston, Massachusetts 02118, United States

New Jersey School of Medicine, Newark, New Jersey 07107, United States

Columbia University, New York, New York 10032, United States

Harlem Hospital Center, New York, New York 10037, United States

New York University School of Medicine, New York, New York 10016, United States

Montreal Chest Institute, Montreal, Quebec H2X 2P4, Canada

Veterans Administration Tennessee Valley Health Care System, Nashville, Tennessee 37232, United States

University of North Texas Health Science Center, Fort Worth, Texas 76104, United States

Houston Veterans Administration Medical Center, Houston, Texas 77030, United States

Audie L Murphy Memorial Veterans Administration Medical Center, San Antonio, Texas 78284, United States

Seattle-King County Health Department, Seattle, Washington 98104, United States

Additional Information

Tuberculosis Trials Consortium (TBTC) web page

Starting date: July 2003
Last updated: March 16, 2007

Page last updated: August 23, 2015

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