Moxifloxacin As Part of a Multi-Drug Regimen For Tuberculosis

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00082173
First received: April 30, 2004
Last updated: March 26, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Proportion of Patients With Sterile Sputum Cultures [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

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
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

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: March 26, 2013
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014