Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:23 PM
Study NCT ID:
NCT05224401
Status:
RECRUITING
Last Update Posted:
2023-08-28
First Post:
2021-12-14
Brief Title:
Pivmecillinam With AmoxicillinClavulanic Acid for Step Down Oral Therapy in ESBL UTIs
Sponsor:
Lund University
Organization:
Lund University
Study Overview
Official Title:
Pivmecillinam With AmoxicillinClavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales PACUTI
Status:
RECRUITING
Status Verified Date:
2023-08
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:
PACUTI
Brief Summary:
To evaluate if the combination of pivmecillinam and clavulanic acid PAC is non-inferior to ciprofloxacin trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in patients with febrile UTI caused by extended spectrum beta-lactamase ESBL producing Enterobacterales EPE
Detailed Description:
A recent observational cohort study supports the notion that beta-lactams can be used with similar efficacy to fluoroquinolones as step down therapy in bacteremic E coli UTIs As such pivmecillinam clavulanic acid PAC constitute an appealing per oral alternative but the combinations safety and efficacy has not been evaluated in a clinical trial The aim of this trial is to investigate whether the PAC combination is non-inferior to ciprofloxacin trimethoprim-sulfamethoxazole or ertapenem as step down oral therapy in treating EPE-causing febrile UTI
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?:
True
Is an FDA AA801 Violation?:
None