1. In a randomized controlled study in Niger, children treated with amoxicillin in addition to standardized nutritional interventions did not experience significantly improved rates of nutritional recovery compared to children treated with nutritional interventions alone.
2. Children in the amoxicillin arm had a significantly lower risk of transfer to inpatient care.
Evidence Rating Level: 1 (Excellent)
Study Rundown: A cornerstone of therapy for children with severe acute malnutrition in the global context has been the use of broad-spectrum antibiotics, irrespective of clinical indications, given the high risk of infections in these individuals. A previous randomized controlled study in Malawi showed a benefit in favor of adding broad-spectrum antibiotics to nutritional replacement but had limited generalizability given the high burden of kwashiorkor and HIV infection.
In this randomized, double-blind placebo-controlled study, there was a head-to-head comparison of outpatient treatment of uncomplicated severe acute malnutrition with and without use of 7 days of amoxicillin. The subjects were children with acute malnutrition living in Niger, with the primary outcome as nutritional recovery at or before week 8. In the primary analysis, there was no significant difference in the likelihood of nutritional recovery at week 8 between the two groups; however, individuals treated with amoxicillin had a significantly lower risk of transfer to inpatient care.
Given its large, randomized design, this study adds substantively to the field given the low prevalence of HIV in this cohort, relative to previous research in the area. However, the findings are limited by the high quality of treatment delivery and follow-up in this study, which may be difficult to replicate in all global settings, and by the fact that only one antibiotic regimen was tested.
Click to read the study, published today in NEJM
Relevant Reading: Antibiotics as Part of the Management of Severe Acute Malnutrition
In-Depth [randomized controlled trial]: This randomized, double-blind placebo-controlled study was conducted in Niger and involved 2399 children; originally a much larger group of 16,241 children were assessed for eligibility, but 13,829 were excluded for a number of reasons, the most likely of which was that they did not reach study criteria for uncomplicated acute malnutrition. The groups were well balanced with respect to a number of factors; on average children were 16.7 months, with mothers who were 26.8 years of age. Children were randomized to a treatment regimen that included standardized outpatient nutritional supplementation (with ready-to-use therapeutic food or RUTF) with or without the addition of 7 days of amoxicillin treatment.
In terms of the primary outcome, there was no significant difference in terms of the likelihood of nutritional recovery at week 8 between the two groups (nutritional recovery achieved in 790 in the amoxicillin group versus 752 in the placebo group, risk ratio 1.05 (95%[CI] 0.99-1.12, P=0.10). There was, however, a lower risk of transfer to inpatient care in the amoxicillin group (26.4% in the amoxicillin group versus 30.7%; risk ratio 0.86 (95% [CI] 0.76-0.98, P=0.01); this finding held specifically for transfers to inpatient care for gastroenteritis, a peculiar finding given that the viruses and parasites responsible for these infections in children are not sensitive to amoxicillin.
Image: PD
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