Supplement

Background: Because access to care is limited in settings with high mortal-ity, exclusive reliance on the current recommendation of 7–10 days of par-enteral antibiotic treatment is a barrier to provision of adequate treatment of newborn infections. Methods: We are conducting a trial to determine if simplified antibiotic regimens with fewer injections are as efficacious as the standard course of parenteral antibiotics for empiric treatment of young infants with clinical signs suggestive of severe infection in 4 urban hospitals and in a rural sur-veillance site in Bangladesh. the reference regimen of intramuscular pro-caine-benzyl penicillin and gentamicin given once daily for 7 days is being compared with (1) intramuscular gentamicin once daily and oral amoxicil-lin twice daily for 7 days and (2) intramuscular penicillin and gentamicin once daily for 2 days followed by oral amoxicillin twice daily for additional 5 days. All regimens are provided in the infant’s home. the primary out-come is treatment failure (death or lack of clinical improvement) within 7 days of enrolment. the sample size is 750 evaluable infants enrolled per treatment group, and results will be reported at the end of 2013. Discussion: the trial builds upon previous studies of community case management of clinical severe infections in young infants conducted by our research team in Bangladesh. the approach although effective was not widely accepted in part because of feasibility concerns about the large num-ber of injections. the proposed research that includes fewer doses of paren-teral antibiotics if shown efficacious will address this concern. Key Words: safety, efficacy, simplified antibiotic regimens, young infants, clinical severe infectio