Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Tuberculosis
About this trial
This is an interventional treatment trial for Tuberculosis
Eligibility Criteria
Inclusion Criteria: Presumptive diagnosis of smear-positive pulmonary TB within 2 weeks of study entry. Patients with both pulmonary and extrapulmonary disease are eligible. Documentation of HIV infection status. If HIV status is unknown at study entry, the participant must consent to testing and results must be available prior to study participation. Agree to use acceptable methods of contraception Exclusion Criteria: History of adverse drug reaction to MOX, INH, RIF, PZA, or EMB Disease or condition for which MOX, INH, RIF, PZA, or EMB is contraindicated History of more than 14 days of continuous antituberculosis therapy during the previous 2 years or more than 2 months of antituberculosis therapy ever Active AIDS-related opportunistic infection or malignancy Currently receiving or planning to receive HIV protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 2 months after study entry Silicotuberculosis Central nervous system TB Pregnant or breastfeeding Unable to take oral medication Electrocardiogram (EKG) QTc interval greater than 450 msec Taking classes IA or III antiarrhythmic agents (quinidine, procainamide, amiodarone, sotalol), cisapride, erythromycin, perphenazine/amitriptyline, phenothiazines, or tricyclic antidepressant Diseases or conditions for which treatment with other drugs with antituberculosis activity (e.g., rifabutin for MAC prophylaxis) is anticipated during the course of the study
Sites / Locations
- Clementino Fraga Filho Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks