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Moxifloxacin for pulmonary tuberculosis (REMoxTB)
NCT00864383Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Oct 2013
- Countries
- 9
- Sponsor
- TB Alliance
- Modality
- Orthosteric Ligands
- Drugs
- moxifloxacin
- Conditions
- pulmonary tuberculosis (TB)
01
Overview
Phase 3, randomised, double-blind trial of moxifloxacin in pulmonary tuberculosis (TB) (3 arms), sponsored by TB Alliance. Primary endpoints: Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy at 18 months and Number of Patients With Grade 3 or 4 Adverse Events at 18 months. Started Jan 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Control (2EHRZ/4HR)
Standard 6-month regimen
Moxifloxacin for Ethambutol (2MHRZ/2MHR)
4-month regimen substituting Ethambutol with Moxifloxacin
Moxifloxacin for Isoniazid (2EMRZ/2MR)
4-month regimen substituting Isoniazid with Moxifloxacin
03
Who it enrols
Adults with smear-positive pulmonary tuberculosis, no prior anti-TB chemotherapy, and no severe comorbidities or HIV with low CD4 count.
04
Endpoints
Primary
Combined Failure of Bacteriological Cure and Relapse Within One Year of Completion of Therapy
Number of Patients With Grade 3 or 4 Adverse Events
Secondary
Number of Patients Who Are Culture Negative (Liquid MGIT Culture)
Time to First Culture Negative Sputum Sample (LJ Solid Media)
05
Results
Not all primary endpoints met
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