A phase III cluster randomised placebo‐controlled trial to assess the efficacy of preventive therapy in child contacts of multidrug‐resistant (MDR) tuberculosis (TB)
This trial specifically targets children less than five years for two reasons. First, children less than five years are at the highest risk of progressing to TB disease following infection. Second, concordance of drug susceptibility is high between adults with MDR‐TB and young child household contacts. This group is therefore most likely to be benefit from MDR‐TB preventive therapy. In addition, global policy and national guidelines in South Africa advocate preventive therapy only for HIV‐negative child contacts less than five years following exposure to a drug‐susceptible TB index case, enhancing the programmatic relevance of our proposed trial. Furthermore, this trial will target children (HIV‐infected and uninfected) under 5 years of age, regardless of tuberculin skin test (TST) status, to ensure programmatic relevance, since WHO and the South African National TB Programme (SA NTP) do not mandate tests of TB infection prior to initiating TB preventive therapy.