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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-04-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Early-Onset Neonatal Sepsis Antibiotic Stewardship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Short duration antibiotic

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

Group Type EXPERIMENTAL

Short duration antibiotics

Intervention Type OTHER

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

Standard duration antibiotic

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

Group Type ACTIVE_COMPARATOR

Standard duration antibiotics

Intervention Type OTHER

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

Interventions

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Short duration antibiotics

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

Intervention Type OTHER

Standard duration antibiotics

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No