NCT03896685

Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Médecins Sans Frontières, France · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB) with fluoroquinolone resistance.

Detailed 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 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 country and 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-disease phenotype and treatment response. 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%.

Conditions

• Tuberculosis, Multidrug-Resistant
• Tuberculosis
• Pulmonary Tuberculoses
• Mycobacterial Infections
• Bacterial Infections
• Gram-Positive Bacterial Infections

Interventions

Type	Name	Description
DRUG	Bedaquiline 100 MG	Bedaquiline: 400 mg QD x 2 weeks, followed by 200 mg 3x/week
DRUG	Delamanid 50 MG Oral Tablet	Delamanid: 100 mg BID
DRUG	Clofazimine 100 MG Oral Capsule	Clofazimine: 100 mg QD
DRUG	Linezolid 600Mg Tab	Linezolid: 600 mg QD up to Week 16, followed by 300 mg QD or 600 mg 3x/week according to a secondary randomization
DRUG	Control arm MDR-TB regimen, designed according to latest WHO guidelines	Control arm MDR-TB regimen, designed according to latest WHO guidelines (might include bedaquiline, delamanid, linezolid, clofazimine, or all of these drugs).

Timeline

• Start date: 2020-04-06
• Primary completion: 2024-10-04
• Completion: 2024-12-31
• First posted: 2019-04-01
• Last updated: 2025-02-10

Locations

10 sites across 6 countries: India, Kazakhstan, Lesotho, Pakistan, Peru, Vietnam