Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633718
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3Multicenter Randomized Double-Blind Positive ControlStudy 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:
No
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:
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