Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT06197269
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2023-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Sponsor:
Lady Hardinge Medical College
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: