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

Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Stewardship; Early-Onset Neonatal Sepsis
• Intervention / Treatment: Other: Short duration antibiotics; Other: Standard duration antibiotics

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110001
      • Lady Hardinge Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short duration antibiotic; antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment	Other: Short duration antibiotics; antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment
Active Comparator: Standard duration antibiotic; Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.	Other: Standard duration antibiotics; Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 'Treatment Failure'	New onset appearance of clinical signs and symptoms requiring initiation of antibiotics	15 days of stopping antibiotics

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lady Hardinge Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): February 14, 2024
• Study Completion (Actual): April 14, 2024

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: December 26, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: LHMC/IEC/2019/41

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No