Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh
Status:
Completed
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
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).
Phase:
N/A
Details
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborator:
Dhaka Shishu Hospital
Treatments:
Amoxicillin Anti-Bacterial Agents Antibiotics, Antitubercular Gentamicins Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins