TBTC Study 28: Moxifloxacin Versus Isoniazid for TB Treatment

Completed · Phase 2

Conditions studied: Tuberculosis

In brief

This double-blind, randomized controlled trial evaluates moxifloxacin versus isoniazid in daily treatment during the first two months of treatment with rifampin, pyrazinamide and ethambutol for sputum smear-positive pulmonary tuberculosis.

Key facts

Study ID

NCT00144417

Run by

Centers for Disease Control and Prevention

People needed

433

Starts

2006-02-01

Expected to finish

2007-12-01

Last updated by the study team

2011-08-03

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 smear of expectorated or induced sputum. Patients whose sputum cultures do not grow M. tuberculosis and those having an M. tuberculosis isolate resistant to (one or more) isoniazid, rifampin, fluoroquinolones, 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. Sputum must be expectorated or induced; smear results from respiratory secretions obtained by bronchoalveolar lavage or bronchial wash may not be used for assessment of study eligibility.
• 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. HIV testing does not need to be repeated if there is written documentation of a positive test (positive ELISA and Western Blot or a plasma HIV-RNA level greater than 5000 copies/ml) at any time in the past.
• 7 (seven) or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment.
• 7 (seven) or fewer days of fluoroquinolone therapy in the 3 months preceding enrollment.
• Age > 18 years
• Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix B).
• Signed informed consent
• Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
• Laboratory parameters done at, or <14 days prior to, screening:
• Serum amino aspartate transferase (AST) activity ≤ 3 times the upper limit of normal
• Serum total bilirubin level ≤ 2.5 times the upper limit of normal
• Serum creatinine level ≤ 2 times the upper limit of normal
• Complete blood count with hemoglobin level of at least 7.0 g/dL
• Complete blood count with platelet count of at least 50,000/mm3
• Serum potassium > 3.5 meq/L
• Negative pregnancy test (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
• Concomitant disorders or conditions for which moxifloxacin (MXF), isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
• Current or planned therapy during the intensive phase of therapy 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 intensive phase of therapy.
• History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine during the intensive phase of therapy.
• Pulmonary silicosis
• Central nervous system TB

Where it is running

• Veterans Administration Medical Center of Arkansas — Little Rock, Arkansas, United States
• 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 Francincisco — 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
• Northwestern University — Chicago, Illinois, United States
• Hines Veterans Administration Medical Center — Hines, Illinois, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• New Jersey School of Medicine — Newark, New Jersey, United States
• Columbia University — New York, New York, United States
• Harlem Hospital, Columbia University — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, 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
• Hopital Universitario Clementino Fraga Filho — Rio de Janeiro, Rio de Janeiro, Brazil
• University of Manitoba — Winnepeg, Manitoba, Canada
• Montreal Chest Institute — Montreal, Quebec, Canada
• Nelson R. Mandela School of Medicine — Durban, KwaZulu-Natal, South Africa
• Agencia de Salut Publica — Barcelona, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.