Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05905055
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-03-02
Brief Title:
P3 Study to Assess Efficacy and Safety of CefepimeNacubactam and AztreonamNacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
Sponsor:
Meiji Seika Pharma Co Ltd
Organization:
Meiji Seika Pharma Co Ltd
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Single-Blind Study to Assess the Efficacy and Safety of CefepimeNacubactam and AztreonamNacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection Acute Uncomplicated Pyelonephritis Hospital-Acquired Bacterial Pneumonia Ventilator Associated Bacterial Pneumonia and Complicated Intra-Abdominal Infection Due to Carbapenem Resistant Enterobacterales
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Integral-2
Brief Summary:
This study is a multi-center randomized single-blind parallel-group study to assess the efficacy and safety when nacubactam is coadministered with cefepime or aztreonam compared with best available therapy BAT in the treatment of patients with cUTI AP HABP VABP and cIAI due to Carbapenem Resistant Enterobacterales
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None