TBTC Study 27: Moxifloxacin vs Ethambutol for TB Treatment

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)