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

Publication date: Available online 7 January 2019Source: The Lancet Respiratory MedicineAuthor(s): Florian von Groote-Bidlingmaier, Ramonde Patientia, Epifanio Sanchez, Vincent Balanag, Eduardo Ticona, Patricia Segura, Elizabeth Cadena, Charles Yu, Andra Cirule, Victor Lizarbe, Edita Davidaviciene, Liliana Domente, Ebrahim Variava, Janice Caoili, Manfrid Danilovits, Virgaine Bielskiene, Suzanne Staples, Norbert Hittel, Carolyn Petersen, Charles WellsSummaryBackgroundDelamanid is one of two recently approved drugs for the treatment of multidrug-resistant tuberculosis. We aimed to evaluate the safety and efficacy of delamanid in the first 6 months of treatment.MethodsThis randomised, double-blind, placebo-controlled, phase 3 trial was done at 17 sites in seven countries (Estonia, Latvia, Lithuania, Moldova, Peru, the Philippines, and South Africa). We enrolled eligible adults (>18 years) with pulmonary multidrug-resistant tuberculosis to receive, in combination with an optimised background regimen developed according to WHO and national guidelines, either oral delamanid (100 mg twice daily) for 2 months followed by 200 mg once daily for 4 months or placebo (same regimen). Patients were centrally randomised (2:1) and stratified by risk category for delayed sputum culture conversion. Primary outcomes were the time to sputum culture conversion over 6 months and the difference in the distribution of time to sputum culture conversion over 6 months between the two groups, as assessed...
Source: The Lancet Respiratory Medicine - Category: Respiratory Medicine Source Type: research