Use of Cefiderocol in the Management of Gram-Negative Infections (PERSEUS)

Shionogi

Status

Completed

Conditions

Gram-Negative Infection

Treatments

Drug: Cefiderocol

Study type

Observational

Funder types

Industry

Identifiers

NCT05789199

2020-266-4

Details and patient eligibility

About

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.

Full 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.

Enrollment

314 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.