Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-03-27 @ 2:09 AM
Study NCT ID:
NCT02714595
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2016-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
Sponsor:
Shionogi
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-label Clinical Study of S-649266 or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03780140
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
CREDIBLE - CR
Brief Summary:
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients caused by carbapenem-resistant Gram-negative pathogens.
Detailed Description:
This study is designed to provide evidence of efficacy of cefiderocol in the treatment of serious infections in adult patients with either hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), complicated urinary tract infection (cUTI), or bloodstream infections (BSI)/sepsis caused by carbapenem-resistant Gram-negative pathogens.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-004703-23 | EUDRACT_NUMBER | None | View |