Tuberculosis Clinical Trial
Official title:
Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
Verified date | March 2013 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | September 2008 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Clementino Fraga Filho Hospital | Rio de Janeiro |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Patients With Sterile Sputum Cultures | Proportion of patients with sterile sputum cultures | 8 weeks | No |
Secondary | Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications | Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications | 8 weeks | Yes |
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