Safety and Efficacy Trial of Delamanid for 6 Months in Participants With Multidrug-resistant Tuberculosis

Summary

The purpose of this trial is to determine whether delamanid is effective in the treatment of multidrug-resistant tuberculosis (MDR TB) in combination with other MDR TB medications during 6 months of treatment.

Timeline

Start

2011-09-02

Primary completion

2016-07-04

Completion

2016-07-04

Outcome

Missed primary endpoint

registry analysis (superiority test); Delamanid + OBR vs Placebo + OBR; p = 0.0562; Modified Peto-Peto test; NCT01424670 ↗

paper The reduction in median time to sputum culture conversion over 6 months was not significant in the primary analysis. PMID 30630778 ↗

Publications

• von Groote-Bidlingmaier F, Patientia R, Sanchez E, Balanag V Jr, Ticona E, Segura P, Cadena E, Yu C, Cirule A, Lizarbe V, Davidaviciene E, Domente L, Variava E, Caoili J, Danilovits M, Bielskiene V, Staples S, Hittel N, Petersen C, Wells C, Hafkin J, Geiter LJ, Gupta R. Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial. Lancet Respir Med. 2019 Mar;7(3):249-259. doi: 10.1016/S2213-2600(18)30426-0. Epub 2019 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delamanid	Small molecule	200 mg	Oral

Indications