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Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

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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

Tracking Information
First Submitted Date  ICMJE April 30, 2004
First Posted Date  ICMJE May 4, 2004
Results First Submitted Date  ICMJE March 26, 2013
Results First Posted Date  ICMJE May 22, 2013
Last Update Posted Date May 22, 2013
Study Start Date  ICMJE October 2004
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
Proportion of Patients With Sterile Sputum Cultures [ Time Frame: 8 weeks ]
Proportion of patients with sterile sputum cultures
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00082173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2013)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis
Official Title  ICMJE Phase 2 Randomized Trial of a Moxifloxacin-Containing Regimen For Treatment of Smear-Positive Pulmonary Tuberculosis in Adults With and Without HIV Infection
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tuberculosis
Intervention  ICMJE Drug: Moxifloxacin
400mg daily for 8 weeks
Other Name: Avelox
Study Arms  ICMJE
  • Experimental: 1
    INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
    Intervention: Drug: Moxifloxacin
  • Placebo Comparator: 2
    INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
    Intervention: Drug: Moxifloxacin
Publications * Conde MB, Efron A, Loredo C, De Souza GR, Graça NP, Cezar MC, Ram M, Chaudhary MA, Bishai WR, Kritski AL, Chaisson RE. Moxifloxacin versus ethambutol in the initial treatment of tuberculosis: a double-blind, randomised, controlled phase II trial. Lancet. 2009 Apr 4;373(9670):1183-9. doi: 10.1016/S0140-6736(09)60333-0.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
170
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00082173
Other Study ID Numbers  ICMJE FD-R-002135-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Richard E. Chaisson, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Richard E. Chaisson, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP