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Sponsors and Collaborators: |
Johns Hopkins University Federal University of Rio de Janeiro |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00728507 |
Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications.
This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis.
The experimental regimen will consist of the following:
The standard control intensive phase regimen will consist of the following:
Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen.
In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.
Condition | Intervention | Phase |
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Tuberculosis |
Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Randomized, Open-Label Trial of a Rifapentine Plus Moxifloxacin-Based Regimen for Intensive Phase Treatment of Smear-Positive Pulmonary Tuberculosis |
Estimated Enrollment: | 216 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
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Drug: Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid
Rifapentine:150mg tablets, dose = 300mg for subjects <= 45kg and 450mg for those >45kg by mouth once a day for 8 weeks; Moxifloxacin 400mg tablet by mouth once a day for 8 weeks, Isoniazid and Pyrazinamide per standard of care for TB treatment.
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2: Active Comparator
Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid.
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Drug: Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Administered per standard of care for TB treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documentation of study baseline laboratory parameters done at, or ≤ 14 days prior to screening:
Exclusion Criteria:
Contact: Susan Dorman, MD | 410-955-1755 | dsusan1@jhmi.edu |
Contact: Anne R Efron, MSN, MPH | 410-502-2803 | aefron@jhmi.edu |
Brazil | |
Hospital Universitario Clementio Fraga Filho | |
Rio de Janeiro, Brazil | |
Hospital Escola Sao Francisco de Assis | |
Rio de Janeiro, Brazil |
Principal Investigator: | Susan Dorman, MD | Johns Hopkins University |
Responsible Party: | Johns Hopkins University Center for Tuberculosis Research ( Dr. Susan Dorman ) |
Study ID Numbers: | 06-0018 |
Study First Received: | July 30, 2008 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00728507 |
Health Authority: | United States: Food and Drug Administration; Brazil: National Committee of Ethics in Research; Brazil: Ethics Committee |
Tuberculosis Moxifloxacin Rifapentine |
Bacterial Infections Rifapentine Pyrazinamide Rifampin Gram-Positive Bacterial Infections Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin |
Lung Diseases Tuberculosis, pulmonary Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis Ethambutol Isoniazid |
Antimetabolites Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Antilipemic Agents Therapeutic Uses |
Antitubercular Agents Fatty Acid Synthesis Inhibitors Pharmacologic Actions Actinomycetales Infections Leprostatic Agents Antibiotics, Antitubercular |