Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06633718
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
Sponsor:
Qilu Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase 3,Multicenter, Randomized, Double-Blind, Positive Control，Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Complicated Intra-abdominal Infections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI).
Detailed Description:
This is a Phase 3, randomized, double-blind, multicenter, positive control study to assess the efficacy, safety, and pharmacokinetics of Meropenem and Pralurbactam compared with Ceftazidime-avibactam in combination with Metronidazole in the treatment of adult complicated intra-abdominal infections (cIAI). Treatment duration for each cohort was 7 to 14 days.
Study Oversight
Has Oversight DMC:
False
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?: