Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03543436
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2018-05-18
Brief Title:
Temocillin Versus a Carbapenem as Initial Intravenous Treatment for ESBL Related Urinary Tract Infections
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Temocillin Versus a Carbapenem as Initial Intravenous Treatment for Extended-spectrum Beta-lactamase Related Urinary Tract Infections a Non-inferiority Study
Status:
COMPLETED
Status Verified Date:
2021-04
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:
TEMO-CARB
Brief Summary:
TEMO-CARB is a phase 3 randomized controlled multicentre open-label pragmatic clinical trial to test the non-inferiority of temocillin versus carbapenem as initial intravenous treatment of Urinary Tract Infection UTI due to extended-spectrum beta-lactamase ESBL producing enterobacteriaceae
Detailed Description:
Urinary tract infections are among the most common bacterial infections that are treated in the community by an empirical antibiotic treatment regimen Enterobacteriaceae are the most common bacteria involved in urinary tract infection Since 2006 extended-spectrum beta-lactamase ESBL producing enterobacteriaceae have spread in France as elsewhere Finding therapeutic alternatives to carbapenems in infections caused by ESBL producing enterobacteriaceae is imperative Although temocillin 6-α-methoxy derivative of ticarcillin has been suggested as a potential alternative to carbapenem therapy for ESBL related infections it was not investigated in accordance with current standard The hypothesis to test in this study is that temocillin is not inferior to a carbapenem as initial intravenous treatment of urinary tract infections caused by ESBL producing enterobacteriaceae
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-001257-14 | EUDRACT_NUMBER | None | None |