NCT06197269

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Lady Hardinge Medical College · Other Government
• Sex: All
• Age: 28 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Early-Onset Neonatal Sepsis
• Antibiotic Stewardship

Interventions

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

Timeline

• Start date: 2022-04-15
• Primary completion: 2024-02-14
• Completion: 2024-04-14
• First posted: 2024-01-09
• Last updated: 2024-08-13

Locations

1 site across 1 country: India