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Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00082173
Recruitment Status : Completed
First Posted : May 4, 2004
Results First Posted : May 22, 2013
Last Update Posted : May 22, 2013
Sponsor:
Information provided by:
Johns Hopkins University

Study Description
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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 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 or disease Intervention/treatment Phase
Tuberculosis Drug: Moxifloxacin Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
 Drug: Moxifloxacin
400mg daily for 8 weeks
Other Name: Avelox
Placebo Comparator: 2
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
Other Name: Avelox


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Patients With Sterile Sputum Cultures [ Time Frame: 8 weeks ]
    Proportion of patients with sterile sputum cultures


Secondary Outcome Measures :
  1. Proportion of Patients With Grade 3 or 4 Adverse Reactions Attributable to Study Medications [ Time Frame: 8 weeks ]
    Proportion of patients with Grade 3 or 4 adverse reactions attributable to study medications


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00082173


Locations
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Brazil
Clementino Fraga Filho Hospital
Rio de Janeiro, Brazil
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Richard E. Chaisson, MD Johns Hopkins University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Richard E. Chaisson, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00082173    
Other Study ID Numbers: FD-R-002135-01
First Posted: May 4, 2004    Key Record Dates
Results First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: March 2013
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Moxifloxacin
 Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents