7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
The optimum duration of intravenous antibiotic therapy for culture-proven neonatal bacterial
sepsis is not known. Current practices, ranging from 7 days to 14 days of antibiotics, are
not evidence-based. This is a randomized, active -controlled, multi-centric, non-inferiority
trial to compare the efficacy of a 7-day course of intravenous antibiotics versus a 14-day
course among neonates weighing > 1000 g at birth with culture-proven bacterial sepsis that is
uncomplicated by meningitis, bone or joint infections deep-seated abscesses. The primary
outcome measure is a definite or probable relapse within 21 days after stoppage of
antibiotics.
Phase:
Phase 3
Details
Lead Sponsor:
Indian Council of Medical Research
Collaborators:
Chacha Nehru Bal Chikitsalaya, New Delhi Indira Gandhi Institute of Child Health, Bangalore Institute of Child Health, Chennai Institute of Obstetrics and Gynecology, Chennai King George's Medical University Lady Hardinge Medical College Lady Hardinge Medical College, New Delhi Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak Postgraduate Institute of Medical Education and Research, Chandigarh St Johns Medical College Hospital, Bangalore