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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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

Criteria

Inclusion Criteria:

• Infants 0-59 days old who are residents of catchment population of the study hospitals

• One or more of the following five signs: severe chest in-drawing, axillary temperature >37.80C or <35.50 C, lethargic or less than normal movement, 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, 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, and/or physician's suspicion of meningitis)

• Very low birth weight: weight <1500

• Hospitalization for illness in the last two weeks

• Hospital born infants

• Previous inclusion in the study