Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789199
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2023-02-16
Brief Title:
Use of Cefiderocol in the Management of Gram-Negative Infections
Sponsor:
Shionogi
Organization:
Shionogi Inc
Study Overview
Official Title:
Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program PERSEUS Study
Status:
COMPLETED
Status Verified Date:
2023-06
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:
PERSEUS
Brief Summary:
The aim of this study is to describe the use of cefiderocol in the management of Gram-negative infections GNIs in participants treated through the Early Access Program EAP in Spain
Detailed Description:
This is a multicenter retrospective chart review of existing medical records in participants who received cefiderocol for a GNI as part of the Shionogi EAP Access to cefiderocol was granted as Medication not approved in Spain subject to RD 10152009 which dictates that each case is approved on an individual basis by the Spanish Agency of Medicines This study will be conducted at Spanish sites where cefiderocol was supplied via the EAP beginning in 2018
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?:
False
Is an FDA AA801 Violation?:
None