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Clinical Trials

MainTitle

Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed
Sponsor
Johns Hopkins University


Information provided by (Responsible Party)
Johns Hopkins University
ClinicalTrials.gov Identifier
NCT00082173

First received: April 30, 2004
Last updated: March 26, 2013
Last Verified: March 2013
History of Changes
Purpose

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 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures

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

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

Arms Assigned Interventions
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

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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

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

Locations

Brazil
Clementino Fraga Filho Hospital
Rio de Janeiro, Brazil

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Richard E. Chaisson, MD Johns Hopkins University
More Information

More Information


Responsible Party: Dr. Richard E. Chaisson, Johns Hopkins University  
ClinicalTrials.gov Identifier: NCT00082173   History of Changes  
Other Study ID Numbers: FD-R-002135-01  
Study First Received: April 30, 2004  
Last Updated: March 26, 2013  

Additional relevant MeSH terms:
Tuberculosis
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination

ClinicalTrials.gov processed this data on October 17, 2017
This information is provided by ClinicalTrials.gov.