Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00082173
• Other study ID #: FD-R-002135-01
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2004
• Last updated: March 26, 2013
• Start date: October 2004
• Est. completion date: September 2008

Study information

• 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

Clinical Trial 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.

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 death worldwide. Appropriate treatment of persons with active TB is very important in limiting the transmission of M. tuberculosis and preventing TB-related mortality. Current therapy requires 6 months of a four-drug regimen of isoniazid (INH), rifampin (RIF), pyrazinamide (PZA), and EMB.

The development of alternative regimens is a priority, and new classes of antituberculosis agents are needed to provide treatment options for patients with drug-resistant disease. This study will evaluate the effectiveness of replacing EMB with MOX in a multi-drug regimen in the initial phase of treatment of smear-positive pulmonary TB in patients with and without HIV infection.

Participants in this study will be randomly assigned to receive either a MOX-containing drug regimen or the standard EMB-containing drug regimen for 8 weeks. Participants will have study visits weekly during these 8 weeks. After 8 weeks, participants will discontinue MOX, EMB, and PZA and will continue taking INH and RFP for 4 months. Participants will have study visits at Months 4, 6, 12, and 18. Study visits will include a medical interview, physical exam, blood and urine tests, and sputum tests for TB.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Drug:
• Moxifloxacin
400mg daily for 8 weeks

Locations

Country	Name	City	State
Brazil	Clementino Fraga Filho Hospital	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

Brazil, 

Outcome

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