New phase 3 clinical trial results for a MDR-TB drug
A phase 3 trial of delamanid, a newer oral drug for treating multidrug-resistant tuberculosis (MDR-TB), found no statistically significant reduction in time to sputum culture conversion when compared to placebo, but that it was safe and well tolerated.
Delamanid is one of the newer drugs for treating TB, but there are lingering concerns about side effects, including an increase in the QT interval, which can cause heart rhythm problems. The World Health Organization (WHO) has classified delamanid as a group C drug, because though phase 2 and 3 clinical trials have shown that it effective and well tolerated, strong evidence for its use as a priority drug is still lacking.
An international research group published its findings of the trial, which spanned four global regions, on Jan 7 in an early online edition of The Lancet Respiratory Medicine.