Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis

Not Applicable

Completed

• Conditions: Antibiotic Stewardship; Early-Onset Neonatal Sepsis
• Interventions: Other: Standard duration antibiotics; Other: Short duration antibiotics

• Registration Number: NCT06197269
• Lead Sponsor: Lady Hardinge Medical College

Brief Summary

Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( \>28weeks and \>1000grams ) with culture negative early onset sepsis.

Detailed Description

Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)

Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics

Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.

Study Timeline

• Study Start: 2022-04-15
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2023-12-26
• Study First Posted: 2024-01-09
• Primary Completion: 2024-02-14
• Study Completion: 2024-04-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

• Antibiotics started based on risk factors
• Infants with major congenital anomalies or syndromes.
• Presence of site specific infections including meningitis, pneumonia
• Neonates suspected to have inborn errors of metabolism
• Neonates with Severe birth asphyxia, (Apgar score at 5min <4 and cord Ph< 7.0,base excess <-16)
• Neonates underwent major surgery in 1st week of life
• Deemed by Doctor in charge to be sick enough to be continued on antibiotics

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard duration antibiotic	Standard duration antibiotics	Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.
Short duration antibiotic	Short duration antibiotics	antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Primary Outcome Measures

Name	Time	Method
Incidence of 'Treatment Failure'	15 days of stopping antibiotics	New onset appearance of clinical signs and symptoms requiring initiation of antibiotics

Secondary Outcome Measures

Name	Time	Method
Mortality	Till 1 month of life	Death due to any reason
Need for additional courses of antibiotic therapy	Till 1 month of life	Additional courses during the study time frame
Length of hospital stay	From date of birth until date of death or discharge whichever come assessed till 1 month of life	Duration of hospital stay

Trial Locations

Locations (1)

Lady Hardinge Medical college; 🇮🇳 New Delhi, Delhi, India