Phase 2
N=146
Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT00082173 ↗Enrolled (actual)
146
Serious AEs
8.2%
Results posted
May 2013
Primary outcome: Primary: Proportion of Patients With Sterile Sputum Cultures — 59; 45 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Moxifloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Sterile Sputum Cultures |
59; 45 | — |
| SECONDARY Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications |
0; 0 | — |
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 needed. This study will evaluate whether using the drug moxifloxacin (MOX) in place of ethambutol (EMB) during the first 8 weeks of treatment will effectively treat TB.
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
Data sourced from ClinicalTrials.gov (NCT00082173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.