7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis

PHASE3CompletedINTERVENTIONAL
Enrollment

261

Participants

Timeline

Start Date

January 1, 2019

Primary Completion Date

January 30, 2023

Study Completion Date

January 31, 2023

Conditions
Infant, NewbornNeonatal SEPSISAnti-bacterial AgentsRecurrence
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."

Trial Locations (7)

110001

Kalawati Saran Childrens Hospital and Lady Hardinge Medical College, New Delhi

110031

Chacha Nehru Bal Chikitsalaya, New Delhi

124001

Pandit BD Sharma Postgraduate Institute of Medical Sciences, Rohtak

160023

Postgraduate Institute of Medical Education and Research, Chandigarh

226003

King Georges Medical University, Lucknow

560029

Indira Gandhi Institute of Child Health, Bangalore

600008

Madras Medical College (for Institute of Obstetrics and Gynaecology), Chennai

All Listed Sponsors
collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

collaborator

Chacha Nehru Bal Chikitsalaya, New Delhi

UNKNOWN

collaborator

Lady Hardinge Medical College

OTHER_GOV

collaborator

Indira Gandhi Institute of Child Health, Bangalore

UNKNOWN

collaborator

Institute of Obstetrics and Gynecology, Chennai

UNKNOWN

collaborator

King George's Medical University

OTHER

collaborator

Pandit Bhagwat Dayal Sharma, PGIMS, Rohtak

OTHER

collaborator

St Johns Medical College Hospital, Bangalore, India

OTHER

lead

Indian Council of Medical Research

OTHER_GOV

NCT03280147 - 7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis | Biotech Hunter | Biotech Hunter