Supplement Background: Infection

in young infants is a major cause of morbidity and mortality in low-middle income countries, with high neonatal mortality rates. timely case management is lifesaving, but the current standard of hospitalization for parenteral antibiotic therapy is not always feasible. Alter-native, simpler antibiotic regimens that could be used in outpatient settings have the potential to save thousands of lives. Methods: this trial aims to determine whether 2 simplified antibiotic regimens are equivalent to the reference therapy with 7 days of once-daily (OD) intramuscular (Im) procaine penicillin and gentamicin for outpatient management of young infants with clinically presumed sys-temic bacterial infection treated in primary health-care clinics in 5 com-munities in Karachi, pakistan. the reference regimen is close to the cur-rent recommendation of the hospital-based intravenous ampicillin and gentamicin therapy for neonatal sepsis. the 2 comparison arms are (1) Im gentamicin OD and oral amoxicillin twice daily for 7 days; and (2) Im penicillin and gentamicin OD for 2 days, followed by oral amoxicil-lin twice daily for 5 days; 2250 “evaluable ” infants will be enrolled. the primary outcome of this trial is treatment failure (death, deterioration or lack of improvement) within 7 days of enrollment. Results are expected by early 2014. Discussion: this trial will determine whether simplified antibiotic regimens with fewer injections in combination with high-dose amoxicillin are equiva-lent to 7 days of Im procaine penicillin and gentamicin in young infants with clinical severe infection. Results will have program and policy impli-cations in countries with limited access to hospital care and high burden of neonatal deaths