7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis

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.

Conditions

• Infant, Newborn
• Neonatal SEPSIS
• Anti-bacterial Agents
• Recurrence

Interventions

DRUG

7-day course of antibiotics

Subjects in the "7-day course of antibiotics" arm of the study will receive no further antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned.

DRUG

14-day course of antibiotics

Subjects in the "14-day course of antibiotics" arm of the study will receive 7 more days of antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  collaborator OTHER

• Chacha Nehru Bal Chikitsalaya, New Delhi

  collaborator UNKNOWN

• Lady Hardinge Medical College

  collaborator OTHER_GOV

• Indira Gandhi Institute of Child Health, Bangalore

  collaborator UNKNOWN

• Institute of Obstetrics and Gynecology, Chennai

  collaborator UNKNOWN

• King George's Medical University

  collaborator OTHER

• Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

  collaborator OTHER

• St Johns Medical College Hospital, Bangalore, India

  collaborator OTHER

• Indian Council of Medical Research

  lead OTHER_GOV

Principal Investigators

• Sourabh Dutta · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Hour

Max Age

28 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2023-01-30

Completion

2023-01-31

Countries

• India

Study Locations