BACKGROUND: Severe acute malnutrition contributes to 1 million deaths among 
children annually. Adding routine antibiotic agents to nutritional therapy may 
increase recovery rates and decrease mortality among children with severe acute 
malnutrition treated in the community.
METHODS: In this randomized, double-blind, placebo-controlled trial, we randomly 
assigned Malawian children, 6 to 59 months of age, with severe acute 
malnutrition to receive amoxicillin, cefdinir, or placebo for 7 days in addition 
to ready-to-use therapeutic food for the outpatient treatment of uncomplicated 
severe acute malnutrition. The primary outcomes were the rate of nutritional 
recovery and the mortality rate.
RESULTS: A total of 2767 children with severe acute malnutrition were enrolled. 
In the amoxicillin, cefdinir, and placebo groups, 88.7%, 90.9%, and 85.1% of the 
children recovered, respectively (relative risk of treatment failure with 
placebo vs. amoxicillin, 1.32; 95% confidence interval [CI], 1.04 to 1.68; 
relative risk with placebo vs. cefdinir, 1.64; 95% CI, 1.27 to 2.11). The 
mortality rates for the three groups were 4.8%, 4.1%, and 7.4%, respectively 
(relative risk of death with placebo vs. amoxicillin, 1.55; 95% CI, 1.07 to 
2.24; relative risk with placebo vs. cefdinir, 1.80; 95% CI, 1.22 to 2.64). 
Among children who recovered, the rate of weight gain was increased among those 
who received antibiotics. No interaction between type of severe acute 
malnutrition and intervention group was observed for either the rate of 
nutritional recovery or the mortality rate.
CONCLUSIONS: The addition of antibiotics to therapeutic regimens for 
uncomplicated severe acute malnutrition was associated with a significant 
improvement in recovery and mortality rates. (Funded by the Hickey Family 
Foundation and others; ClinicalTrials.gov number, NCT01000298.).