NCT05789199

Use of Cefiderocol in the Management of Gram-Negative Infections

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
• Phase: —
• Study type: Observational
• Enrollment: 314 (actual)
• Sponsor: Shionogi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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 1015/2009, 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.

Conditions

• Gram-Negative Infection

Interventions

Type	Name	Description
DRUG	Cefiderocol	Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.

Timeline

• Start date: 2022-07-31
• Primary completion: 2023-06-16
• Completion: 2023-06-16
• First posted: 2023-03-29
• Last updated: 2023-06-26

Locations

55 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study