TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

Completed · Phase 2

Conditions studied: Tuberculosis, Pulmonary

In brief

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.

Key facts

Study ID

NCT00140309

Run by

Centers for Disease Control and Prevention

People needed

350

Starts

2003-07-01

Expected to finish

2005-12-01

Last updated by the study team

2007-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Southern California Medical Center — Los Angeles, California, United States
• University of California at San Diego — San Diego, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Denver Public Health Department — Denver, Colorado, United States
• Washington DC Veterans Administration Medical Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Hines Vetrans Administration Medical Center — Hines, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• New Jersey School of Medicine — Newark, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• Columbia University — New York, New York, United States
• Harlem Hospital Center — New York, New York, United States
• Veterans Administration Tennessee Valley Health Care System — Nashville, Tennessee, United States
• University of North Texas Health Science Center — Fort Worth, Texas, United States
• Houston Veterans Administration Medical Center — Houston, Texas, United States
• Audie L Murphy Memorial Veterans Administration Medical Center — San Antonio, Texas, United States
• Seattle-King County Health Department — Seattle, Washington, United States
• University of British Columbia — Vancouver, British Columbia, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• Montreal Chest Institute — Montreal, Quebec, Canada
• Nelson R Mandela School of Medicine — Durban, KwaZulu-Natal, South Africa
• Makerere University Medical School — Kampala, Uganda

Full record on ClinicalTrials.gov

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