Ginsburg AS, Mvalo T, Nkwopara E, et al. Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children. N Engl J Med. 2020 Jul 2;383(1):13-23. doi: 10.1056/NEJMoa1912400. (Original study)
Abstract
BACKGROUND: Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking.
METHODS: We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 1.5="" 14.="" 14="" 2="" 3-day="" 3="" 5-day="" 59="" 5="" 6="" age="" along="" amoxicillin="" analyses="" and="" assessment="" assigned="" be="" breathing="" by="" chest-indrawing="" chest="" children="" daily="" day="" days.="" days="" difficulty="" either="" failure="" fast="" followed="" for="" group.="" group="" had="" human="" if="" immunodeficiency="" in="" included="" indrawing="" infected="" months="" more="" no="" noninferiority="" not="" of="" or="" outcome="" p="" percentage="" pneumonia="" prespecified="" primary="" randomly="" receive="" regimen="" relapse="" secondary="" shown="" than="" that="" the="" times="" to="" treatment="" twice="" virus="" visible="" wall="" was="" were="" who="" with="" without="" would="">
RESULTS: From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], -0.9 to 2.4) - a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, -0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group).
CONCLUSIONS: In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02678195.).
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