NCT01027429

Simplified Antibiotic Therapy for Sepsis in Young Infants

Simplified Antibiotic Regimens for the Management of Sepsis in Young Infants in First-level Facilities: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,543 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 59 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective To evaluate if out-patient (clinic-based) therapy of young infants with possible serious bacterial infection with 7 days of intramuscular procaine penicillin and gentamicin (reference therapy) is equivalent to: * (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 Hypothesis The proportion of babies who fail therapy at (or before 7) days will be 10% in each group. A 5% or less difference in failure rates will be considered equivalent. Study Design This will be a randomized, three arm, open-label equivalence trial among young infants, 0-59 days of age who are diagnosed as having possible serious bacterial infection in one of the Karachi field clinics, and whose families refuse facilitated hospital referral, and the infants meet other specified inclusion criteria. Eligible young infants will be recruited from among those referred to the clinics by trained community health workers as having clinical signs predictive of possible serious illness during regular home visits in the surveillance area, or those presenting directly to the clinics from the areas under pregnancy and newborn surveillance. A diagnosis of possible sepsis will be made by clinicians if specified clinical criteria are met.

Conditions

• Neonatal Sepsis
• Sepsis
• Infection

Interventions

Type	Name	Description
DRUG	procaine penicillin and gentamicin	procaine penicillin 50,000 units/kg by intramuscular injection once daily for 7 days; gentamicin, 5 mg/kg once daily by intramuscular injection for 7 days
DRUG	amoxicillin and gentamicin	oral amoxicillin 80-90 mg/kg divided in two doses for 7 days intramuscular gentamicin, 5 mg/kg once daily for 7 days
DRUG	procaine penicillin, gentamicin, amoxicillin	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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2009-12-08
• Last updated: 2015-06-29

Locations

1 site across 1 country: Pakistan