Simplified Antibiotic Therapy for Sepsis in Young Infants (SATT)
Neonatal Sepsis, Sepsis, Infection
About this trial
This is an interventional treatment trial for Neonatal Sepsis focused on measuring infant, newborn, sepsis, infection, community
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria
- Infants 0-59 days old who are residents of catchment population of the study hospitals or clinics
- One or more of the following five signs: severe chest in-drawing, axillary temperature >38.0C or <35.50 C, movement only when stimulated, and history of feeding problems (confirmed by poor suck on feeding assessment)
- Family refuses recommended hospitalization or hospitalization otherwise not feasible
- Informed consent by a legal guardian.
- Exclusion Criteria:
Very severe infection/disease characterized by presence of any of the following signs (unconscious, convulsions, unable to feed, apnea, unable to cry, cyanosis, bulging fontanel, prolonged capillary refill, major congenital malformations, major bleeding, surgical conditions needing hospital referral, persistent vomiting defined as vomiting following three attempts to feed the baby within ½ hour)
- Very low birth weight: weight <1500
- Hospitalization for illness in the last two weeks
- Previous inclusion in the study
Sites / Locations
- Ali Akber Shah Goth
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
procaine penicillin and gentamicin
Amoxicillin and gentamicin
procaine penicillin, gentamicin, and amoxicillin
Procaine penicillin, 50,000 IU/kg by intramuscular injection plus gentamicin, 5 mg/kg intramuscular injection, both given once daily for 7 days
Oral amoxicillin (80-90 mg/kg) divided twice daily and intramuscular gentamicin, 5 mg/kg once daily, both given for 7 days
procaine penicillin, 50,000 IU/kg once daily intramuscular injection plus gentamicin 5 mg/kg once daily intramuscular injection for 2 days, followed by 5 days of oral amoxicillin, 80-90 mg/kg divided in two doses.