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

N/ACompletedNCT06197269

Lady Hardinge Medical College75 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Early-Onset Neonatal Sepsis Antibiotic Stewardship

Interventions

Short duration antibioticsOTHER

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

Standard duration antibioticsOTHER

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

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 36 Weeks

Medical Language ↔ Plain English

Inclusion Criteria (All must be present) * 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 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

Locations (1)

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Incidence of 'Treatment Failure'

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

Time frame: 15 days of stopping antibiotics

Secondary Outcomes

Mortality

Death due to any reason

Time frame: Till 1 month of life

Need for additional courses of antibiotic therapy

Additional courses during the study time frame

Time frame: Till 1 month of life

Length of hospital stay

Duration of hospital stay

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

Data from ClinicalTrials.gov

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