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

NCT06197269 | Completed

• 1 other identifier: LHMC/IEC/2019/41
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Early-Onset Neonatal Sepsis; Antibiotic Stewardship

Outcome Measures

Primary Outcomes (1)

• Incidence of 'Treatment Failure'

  New onset appearance of clinical signs and symptoms requiring initiation of antibiotics

  15 days of stopping antibiotics

Secondary Outcomes (3)

• Mortality

  Till 1 month of life

• Need for additional courses of antibiotic therapy

  Till 1 month of life

• Length of hospital stay

  From date of birth until date of death or discharge whichever come assessed till 1 month of life

Study Arms (2)

Short duration antibiotic

EXPERIMENTAL

antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Other: Short duration antibiotics

Standard duration antibiotic

ACTIVE COMPARATOR

Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

Other: Standard duration antibiotics

Interventions

Short duration antibiotics OTHER

antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Short duration antibiotic

Standard duration antibiotics OTHER

Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

Standard duration antibiotic

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All Preterm neonates (Gestational age \>28weeks and \>1000grams)
• age less than 72hours of life
• Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
• Symptoms resolved at time of randomization

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Hardinge Medical College: lead

Study Sites (1)

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, 110001, India

Location

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Professor & Head, Department of Neonatology

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 9, 2024
• Study Start: April 15, 2022
• Primary Completion: February 14, 2024
• Study Completion: April 14, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)