Status:
COMPLETED
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Lead Sponsor:
Johns Hopkins University
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Current treatment of tuberculosis (TB) requires patients to take four drugs for 8 weeks and then two drugs for 4 months. New drug regimens that are shorter and effective against drug-resistant TB are ...
Detailed Description
Approximately one-third of the world's population is infected with Mycoplasma tuberculosis; 7 to 8 million new cases of active TB occur each year. TB is the second most common infectious cause of deat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT00082173
Start Date
October 1 2004
End Date
September 1 2008
Last Update
May 22 2013
Active Locations (1)
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1
Clementino Fraga Filho Hospital
Rio de Janeiro, Rio de Janeiro, Brazil