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Clinical trial

Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)

ID
Name
2020-266-4
Description
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.
Trial arms
Trial start
2022-07-31
Estimated PCD
2023-06-16
Trial end
2023-06-16
Status
Completed
Treatment
Cefiderocol
Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.
Arms:
Cefiderocol Treated
Size
314
Primary endpoint
Rate Of Clinical Success
From Day 1 (cefiderocol initiation) through Day 28
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Microbiological samples representative of the infection, when available, will be sent by investigating sites to a third party for characterization and analysis. The results of this microbiological characterization will be inputted into the database linked to the participant episode via the electronic study case record form.'}, 'enrollmentInfo': {'count': 314, 'type': 'ACTUAL'}}
Updated at
2023-06-26

1 organization

1 product

1 indication

Organization
Shionogi
Product
Cefiderocol
Indication
Gram-Negative Infection