Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472271
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-18
Brief Title:
Colistin Dosage Prsonalization Approach
Sponsor:
Mahmoud I Mostafa
Organization:
Helwan University
Study Overview
Official Title:
Colistin in Neonatal ICU Patients With Gram Negative Resistant Infection Dosage Personalization Approach
Status:
RECRUITING
Status Verified Date:
2024-06
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:
A few studies have evaluated higher doses or the administration or a loading dose which is routine in adults in pediatric patients and reported improved colistin exposure without an increased risk of nephrotoxicity The main questions it aims to answer are What is the optimal dosing strategies of intravenous colistin for the treatment of multidrug-resistant gram-negative bacterial infections in preterm neonates What is the incidence of AKI What is the factors increasing AKI incidence A single center retrospective and comparative study cohort study compare low dose 5 mgkgday versus 75mgkgday
Detailed Description:
Retrospective study to measure safety and efficacy of colistin conventional dose versus high dose then prospective design to measure pharmacokinetics parameter of both doses to design optimal dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None