Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis - Full Text View

Sponsored by:	Food and Drug Administration (FDA)
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00082173

Purpose

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.

Condition	Intervention	Phase
Tuberculosis	Drug: Moxifloxacin	Phase II

MedlinePlus related topics: Tuberculosis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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

Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:

Proportion of patients with sterile sputum cultures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Proportion of patients with sterile sputum [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Proportion of patients with any grade 3 or 4 adverse reaction [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	170
Study Start Date:	October 2004
Estimated Study Completion Date:	September 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks	Drug: Moxifloxacin 400mg daily for 8 weeks
2: Placebo Comparator INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks	Drug: Moxifloxacin 400mg daily for 8 weeks

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082173

Locations

Brazil
Clementino Fraga Filho Hospital
Rio de Janeiro, Brazil

Sponsors and Collaborators

Food and Drug Administration (FDA)

Investigators

Principal Investigator:

Richard E. Chaisson, MD

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University ( Dr. Richard E. Chaisson )
Study ID Numbers:	FD-R-002135-01
Study First Received:	April 30, 2004
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00082173
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Moxifloxacin
HIV Infections
Tuberculosis, pulmonary

Acquired Immunodeficiency Syndrome
Tuberculosis, Pulmonary
Mycobacterium Infections
Tuberculosis

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 15, 2009