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    Home > Active Ingredient News > Infection > NEJM: Short-term treatment of non-severe tuberculosis in children in Africa and India

    NEJM: Short-term treatment of non-severe tuberculosis in children in Africa and India

    • Last Update: 2022-04-19
    • Source: Internet
    • Author: User
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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
    .

    child

    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

    .
    The primary safety outcome of the study was a grade 3 or higher adverse event during treatment and up to 30 days after treatment

    .

    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.
    5 years (range, 2 months to 15 years), 52% were male, 11% had
    HIV infection , and 14% had bacteriologically confirmed tuberculosis
    .
    Retention by 72 weeks was 95%, and adherence to assigned therapy was 94%

    .
    The primary outcome event occurred in 16 participants (3%) in the 4-month group and 18 (3%) in the 6-month group (adjusted difference -0.
    4 percentage points; 95% confidence interval of -2.
    2 to 1.
    5)

    .
    The non-inferiority of 4-month treatment was consistent across intention-to-treat, per-protocol, and key secondary analyses, including when the analysis was limited to 958 participants (80%) who were independently adjudicated at baseline have tuberculosis

    .
    A total of 95 participants (8%) in the study had adverse events of grade 3 or higher, including 15 adverse drug reactions (11 hepatic events, all but 2 in the first 8 weeks )

    .

    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
    .

    For children with drug-sensitive, non-severe, smear-negative TB, 4 months of anti-TB treatment was noninferior to 6 months of treatment
    .

    Original source:
     
    Anna Turkova, et al.
    Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children .
    NEJM.
    2022.
    https:// Source:


    Shorter Treatment for Nonsevere Tuberculosis in African and Indian Children

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