Evaluation of a Moxifloxacin-Based, Isoniazid-Sparing Regimen for Tuberculosis Treatment TBTC/UITB Study 28 - Moxifloxacin for Isoniazid

• Conditions: To compare two treatments for pulmonary tuberculosis

• Registration Number: EUCTR2005-003312-29-ES
• Lead Sponsor: TB Investigation Unit of Barcelona

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 410

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 isoniazid, rifampin, fluoroquinolones, or any 2 study drugs 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. 14 or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment
4. 10 or fewer days of treatment with a fluoroquinolone during the 3 months preceding enrollment
5. Age > 18 years
6. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs)
7. Signed informed consent
8. 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.
9. 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 > 3.0 meq/L
? Negative pregnancy test (for women of childbearing potential)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Breast-feeding
2. Known intolerance to any of the study drugs
3. Known allergy to any fluoroquinolone antibiotic
4. Concomitant disorders or conditions for which moxifloxacin, isoniazid, rifampin, pyrazinamide, or ethambutol are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gout.
5. Current or planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy)
6. Current or planned antiretroviral therapy during the intensive phase of tuberculosis treatment
7. History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment.
8. Pulmonary silicosis
9. Central nervous system TB

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified