Status:
COMPLETED
7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis
Lead Sponsor:
Indian Council of Medical Research
Collaborating Sponsors:
Post Graduate Institute of Medical Education and Research, Chandigarh
Chacha Nehru Bal Chikitsalaya, New Delhi
Conditions:
Infant, Newborn
Neonatal SEPSIS
Eligibility:
All Genders
1-28 years
Phase:
PHASE3
Brief 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-bas...
Detailed Description
The optimum duration of intravenous antibiotic therapy for uncomplicated neonatal bacterial septicemia is not known. Pediatricians administer anywhere between 7 to 14 days of antibiotics, but these pr...
Eligibility Criteria
Inclusion
- Inclusion criteria for the initial observation part of study preceding randomization
- Neonates aged 0-28 days, either inborn or outborn, who are currently admitted in the Neonatal Unit of the centre.
- Whose birth weight is greater than or equal to1000 grams (it should be reliably ascertained from records of a hospital)
- Whose residence is within approximately 15 kms from the center, so that the infant can be brought back to the center for follow-up
- Who have suspected septicemia for which a conventional or BACTEC/BACTALERT blood culture is sent and for which the treating physician decides to start antibiotics
- Inclusion criteria for Randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Positive blood culture other than Staphylococcus aureus
- No signs and symptoms of sepsis from end of day 5 through end of day 7 of starting sensitive antibiotics
Exclusion
- Exclusion criteria for the initial observation part of study preceding randomization:
- Central Nervous System infection (Central Nervous System infection (meningitis will be defined as CSF Cells \>25 per uL with polys \>60% OR \[(CSF glucose \<20 mg/dL OR CSF:blood\* glu ratio \<0.6) AND (CSF protein \>150 mg/dL in term OR \>180 mg/dL in preterm)\]
- Septic arthritis, osteomyelitis or deep-seated abscess as clinically judged by the treating team
- Life threatening congenital malformations as judged by the principal investigator of the centre
- Exclusion criteria for randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Sterile blood culture
- Suspected contaminants in blood culture.
- Growth of Staphylococcus aureus in blood culture
- Growth of fungal organism in blood culture
- Diagnosis of meningitis, septic arthritis, osteomyelitis, abscess
- Has not gone into remission on day 5 or have recurrence of symptoms from day 5 through day 7
- If the empiric antibiotic is resistant but neonate has shown improvement of signs and symptoms of sepsis and there is ambiguity regarding in vivo sensitivity of antibiotic use
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT03280147
Start Date
January 1 2019
End Date
January 31 2023
Last Update
November 2 2023
Active Locations (7)
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1
Pandit BD Sharma Postgraduate Institute of Medical Sciences
Rohtak, Haryana, India, 124001
2
Indira Gandhi Institute of Child Health
Bangalore, Karnataka, India, 560029
3
Madras Medical College (for Institute of Obstetrics and Gynaecology)
Chennai, Tamil Nadu, India, 600008
4
King Georges Medical University
Lucknow, Uttar Pradesh, India, 226003