Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06197269
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-12-26
Brief Title:
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
Sponsor:
Lady Hardinge Medical College
Organization:
Lady Hardinge Medical College
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 antibiotic5 - 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 antibiotic5 - 7days
Short duration antibiotic group Antibiotic therapy stopped at the time of randomization ie 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 ie 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:
None
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?:
None