Evaluating Newly Approved Drugs for Multidrug-resistant TB (endTB): A Clinical Trial

NCT02754765 Phase 3 COMPLETED

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

Details

Lead sponsor	Médecins Sans Frontières, France
Phase	Phase 3
Status	COMPLETED
Enrolment	754
Start date	2016-12
Completion	2023-06

Conditions

• Tuberculosis, Multidrug-Resistant
• Infection, Bacterial
• Pulmonary Tuberculoses

Interventions

• Bedaquiline
• Delamanid
• Clofazimine
• Levofloxacin
• Moxifloxacin
• Linezolid
• Pyrazinamide
• Control arm MDR-TB regimen, consistent with WHO guidelines

Primary outcomes

• Week 73 Efficacy — Week 73 after randomization
  Proportion of participants with favorable outcome at week 73. A participant's outcome will be classified as favorable at week 73 if the outcome is not classified as unfavorable, and one of the following is true: * The last two culture results are negative. These two cultures must be taken from sputum samples collected on separate visits, the latest between weeks 65 and 73; * The last culture result (from a sputum sample collected between weeks 65 and 73) is negative; and either there is no other post-baseline culture result or the penultimate culture result is positive due to laboratory cross contamination; and bacteriological, radiological and clinical evolution is favorable; * There is no culture result from a sputum sample collected between weeks 65 and 73 or the result of that culture is positive due to laboratory cross contamination; and the most recent culture result is negative; and bacteriological, radiological and clinical evolution is favorable.

Countries

Georgia, India, Kazakhstan, Lesotho, Pakistan, Peru, South Africa