Mycobacterial disease · Shortening treatment in children
Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children
| Design | Open-label, randomised, controlled non-inferiority trial |
|---|---|
| Treatment | Four months of antituberculosis treatment |
| Control | Six months of antituberculosis treatment |
| Population | 1204 children with drug-susceptible, non-severe, smear-negative tuberculosis; median age 3.5 years, 11% with HIV, 14% bacteriologically confirmed |
| Follow-up | 72 weeks |
| Primary endpoint | Composite unfavourable outcome of treatment failure, recurrence or death by 72 weeks |
| Result | A primary-outcome event occurred in 16 of 602 (3%) in the four-month group and 18 of 602 (3%) in the six-month group — adjusted difference -0.4 percentage points (95% CI -2.2 to 1.5), meeting non-inferiority. Retention at 72 weeks was 95% and adherence 94%. Grade 3 or higher adverse events occurred in 95 participants (8%), including 15 adverse drug reactions; 11 were hepatic and all but two arose in the first 8 weeks, when both groups received the same treatment. |
| Secondary endpoints | Adverse events, adherence, retention |
Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis.
The trial authors, in the published abstract
Paediatric tuberculosis had been treated by extrapolation from adult trials for decades. This one enrolled children with the disease children actually get — paucibacillary, smear-negative, non-severe — and shortened their treatment by a third. The eligibility criteria are strict and do the selecting.
Turkova A, Wills GH, Wobudeya E, et al. Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children. N Engl J Med 2022 Mar 10;386(10):911-922.