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Two-thirds of children with TB have non-severe disease that can be treated with a shorter regimen than the current six-month regimen
.
In a recent study published in the top medical journal NEJM, researchers conducted an open-label, shorter-duration, non-inferiority trial in Uganda, Zambia, South Africa, and India involving non-serious, symptomatic, potentially adverse effects.
Drug-susceptible children with smear-negative tuberculosis
.
Children under the age of 16 were randomly assigned to receive either 4 months (16 weeks) or 6 months (24 weeks) of standard first-line antituberculosis therapy using a fixed pediatric proportional-dose combination, as recommended by the World Health Organization
The primary efficacy outcome of the study was adverse status at 72 weeks (treatment failure [extending, changing or restarting treatment or TB relapse], loss to follow-up or death during treatment), excluding participants who did not complete 4 months of treatment (modified intent-to-treat population)
.
The researchers used a noninferiority margin of 6 percentage points
From July 2016 to July 2018, a total of 1204 children in the study were randomized (602 in each group)
.
The median age of participants was 3.
immune infection
Thus, for children with drug-sensitive, non-severe, smear-negative tuberculosis, 4-month anti-TB treatment was not inferior to 6-month treatment
.
.
Original source:
Anna Turkova, et al.
Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children .
NEJM.