Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03357614
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2017-11-20
Brief Title:
Sulopenem Followed by Sulopenem-etzadroxilProbenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
Sponsor:
Iterum Therapeutics International Limited
Organization:
Iterum Therapeutics International Limited
Study Overview
Official Title:
Prospective Phase 3 Randomized Multi-center Double-blind Double-dummy Study of Efficacy Tolerability Safety of Sulopenem Followed by Sulopenem-etzadroxilProbenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults
Status:
COMPLETED
Status Verified Date:
2019-11
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 is a prospective phase 3 randomized multicenter double-blind double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxilprobenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections cUTI in adults
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None