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)

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.

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.

Inclusion Criteria:

• Have received first course of cefiderocol.
• Have received treatment for at least 72 hours (complete) with cefiderocol as a part of clinical compassionate management, requested in the EAP.

Exclusion Criteria:

• Enrolled in any clinical trial of an investigational product.
• Documented Acinetobacter spp infection.
• Incomplete medical records for the following essential data elements:
• Cefiderocol usage (dose, duration, frequency)
• Data to be able to determine clinical success (primary objective)
• Co-infection with a GNB resistant to cefiderocol in 28 days of the initial dose of cefiderocol.