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

Antibiotic Stewardship Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06197269
• Other study ID #: LHMC/IEC/2019/41
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: April 14, 2024

Study information

• Verified date: December 2023
• Source: Lady Hardinge Medical College
• Contact: Sushma Nangia, DM (Neo)
• Phone: 9810838181
• Email: drsnangia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 14, 2024
• Est. primary completion date: February 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Stewardship
• Early-Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
India	Lady Hardinge Medical college	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of 'Treatment Failure'	New onset appearance of clinical signs and symptoms requiring initiation of antibiotics	15 days of stopping antibiotics
Secondary	Mortality	Death due to any reason	Till 1 month of life
Secondary	Need for additional courses of antibiotic therapy	Additional courses during the study time frame	Till 1 month of life
Secondary	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