This is a Phase III, open-label, multi-center trial with a cluster-randomized superiority design. The purpose of the study is to compare the efficacy and safety of 26 weeks of Delamanid (DLM) versus 26 weeks of isoniazid (INH) for preventing confirmed or probable active TB during 96 weeks of follow-up among high-risk household contacts (HHCs) of adults with multidrug-resistant tuberculosis (MDR-TB). High-risk HHCs are those with HIV or non-HIV immunosuppression, latent TB infection, and young children below the age of 5 years.
The study tests the hypothesis that treating household contacts (children, adolescents, and adults) of multidrug-resistant tuberculosis (MDR-TB) patients, including those with pre-extensively (pre-XDR) and extensively drug resistant (XDR) TB, who are at high risk of developing TB with delamanid (DLM), will substantially reduce the risk of developing TB compared with treatment with isoniazid (INH) preventive therapy.
Expected impact: To inform global TB prevention guidelines, where we have Delamanid as a safe and effective option for TB preventive treatment.
Recruitment rate: 114%
Retention Rate: 100%
