Simplified Antibiotic Therapy for Sepsis in Young Infants

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial evaluates primary care clinic-based simplified antibiotic therapy options for young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where hospital referral is frequently refused by families.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborators: Emory University; London School of Hygiene and Tropical Medicine; Save the Children; World Health Organization
• Treatments: Amoxicillin; Anti-Bacterial Agents; Gentamicins; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins; Procaine

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