Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-01 @ 5:16 PM
Study NCT ID:
NCT03925402
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2019-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
Sponsor:
Phramongkutklao College of Medicine and Hospital
Organization:
Study Overview
Official Title:
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis
Status:
COMPLETED
Status Verified Date:
2023-03
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:
This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.
Detailed Description:
There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.
Study Oversight
Has Oversight DMC:
False
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?: