Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 500
Summary
- Conditions
- Bacterial Infections
- Gram Positive Bacterial Infections
- Mycobacterial Infections
- Pulmonary Tuberculoses
- Tuberculosis
- Tuberculosis, Multidrug Resistant
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 125 years
- Gender
- Both males and females
Description
This is a Phase III, randomized, controlled, open-label, multi-country trial evaluating the efficacy of new combination regimens for treatment of fluoroquinolone-resistant MDR-TB. Regimens examined combine newly approved drugs bedaquiline and delamanid with existing drugs known to be active against ...
This is a Phase III, randomized, controlled, open-label, multi-country trial evaluating the efficacy of new combination regimens for treatment of fluoroquinolone-resistant MDR-TB. Regimens examined combine newly approved drugs bedaquiline and delamanid with existing drugs known to be active against Mycobacterium tuberculosis (linezolid and clofazimine). The study will enroll in parallel across 1 experimental and 1 standard-of-care control arms, in a 2:1 ratio. Randomization will be stratified by extent-of-TB-disease phenotype. In the experimental arm, treatment will be for 24 or 39 weeks; duration will be assigned according to extent-of-TB-diseasephenotype. In the control arm, treatment will be delivered according to WHO guidelines (and local practice); duration will be variable. Trial participation in both arms will last at least until Week 73, and up to Week 104. Non-inferiority will be established for the experimental arm if the lower bound of the one-sided 97.5% confidence interval around the difference in favorable outcome between the control and experimental arms is greater than or equal to -12%.
Tracking Information
- NCT #
- NCT03896685
- Collaborators
- Partners in Health
- Harvard Medical School
- Epicentre
- Institute of Tropical Medicine, Belgium
- Socios En Salud, Peru
- Interactive Research and Development
- Investigators
- Principal Investigator: Lorenzo Guglielmetti, MD Médecins Sans Frontières, France Principal Investigator: Carole Mitnick, Sc.D Harvard Medical School