Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01543347
Status:
WITHDRAWN
Last Update Posted:
2013-01-29
First Post:
2012-02-22
Brief Title:
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases ESBLAmpC Enterobacteriaceae
Sponsor:
Belpharma sa
Organization:
Belpharma sa
Study Overview
Official Title:
Temocillin Use in Complicated Urinary Tract Infections Due to Extended Spectrum Beta-Lactamases ESBL Producing and AmpC Hyperproducing Enterobacteriaceae in United Kingdom
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No patient has been included in 9 months because of strict inclexcl criteria
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEA
Brief Summary:
This study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection UTI due to confirmed Extended Spectrum Beta-Lactamases ESBL producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom
Detailed Description:
The spectrum of activity together with the route of excretion of temocillin makes it a good candidate for the treatment of urinary tract infections Several studies have shown very good clinical and microbiological activity in uncomplicated and complicated cystitis and pyelonephritis in adults and in pyelonephritis in children older than 2 months However there is no specific study performed on Urinary Tract Infections due to broad spectrum ß-lactamases producing strains
In this context this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases ESBL producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection
In this context this study is aimed at demonstrating the efficacy of temocillin in the treatment of complicated Urinary Tract Infection due to confirmed Extended Spectrum Beta-Lactamases ESBL producing or AmpC hyperproducing Enterobacteriaceae in the United Kingdom The investigators will also evaluate the tolerance of the drug by monitoring the adverse event and the incidence of eventual Clostridium difficile associated infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2008-005912-41 | EUDRACT_NUMBER | None | None |