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Safety and Efficacy of Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
The primary aim is to establish the non-inferiority of several simplified, home-based antibiotic regimens compared to the standard course of parenteral antibiotics for the empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse hospitalization. Three alternative regimens will be compared with a standard (reference) regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily for five days. Hypothesis The proportion who fails treatment will be 10 percent in the reference group and the alternative treatment groups. An alternative therapy will be considered non-inferior to the standard therapy if the failure rate in the alternative therapy exceeds the failure rate in the injectable therapy by less than 5 absolute percentage points. Secondary Objectives: * To identify baseline clinical predictors of treatment failure in severe infections in young infants. * To determine the proportion of relapse (young infants who were considered cured by day 7 but developed any of the signs of suspected severe infection by day 14).
Details
| Lead sponsor | Johns Hopkins Bloomberg School of Public Health |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 2490 |
| Start date | 2009-03 |
| Completion | 2013-09 |
Conditions
- Sepsis
Interventions
- Gentamicin & Amoxicillin x 7days
- Penicillin & gentamicin x 2 d + Amoxicillin X 5 d
- Standard reference therapy
Primary outcomes
- Treatment failure — Seven days
Countries
Bangladesh