Use of Cefiderocol in the Management of Gram-Negative Infections
PERSEUS
Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)
1 other identifier
observational
314
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2022
Shorter than P25 for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2022
CompletedFirst Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2023
CompletedJune 26, 2023
June 1, 2023
11 months
February 16, 2023
June 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate Of Clinical Success
The rate of clinical success will be reported as the percent clinical success of participants treated with cefiderocol for participants who receive at least 72 hours of cefiderocol through the EAP for the treatment of Gram-negative, carbapenem-resistant infections (except for Acinetobacter spp).
From Day 1 (cefiderocol initiation) through Day 28
Secondary Outcomes (10)
Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol
Day 1 (cefiderocol initiation), every 7 days up to Day 28
In-hospital Length of Stay
Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Length of Stay in Intensive Care Unit (ICU)
Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Length of Invasive Ventilation
Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
All-cause In-hospital Mortality
Day 14, Day 28
- +5 more secondary outcomes
Study Arms (1)
Cefiderocol Treated
Participants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.
Interventions
Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.
Eligibility Criteria
Participants treated with cefiderocol for GNIs through the EAP in Spain.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shionogilead
Study Sites (55)
Complejo Hospitalario Universitario A Coruña
A Coruña, Spain
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital General Universitario de Alicante Doctor Balmis
Alicante, Spain
Hospital Universitario de Torrevieja
Alicante, Spain
Hospital Universitario San Juan de Alicante
Alicante, Spain
Hospital Vega Baja de Orihuela
Alicante, Spain
Hospital Universitario Torrecardenas, Almeria
Almería, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Spain
Hospital Clínic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Cruces
Bilbao, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital General Universitario de Elche
Elche, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario de Guadalajara, Guadalajara
Guadalajara, Spain
Complejo Hospitalario de Jaén
Jaén, Spain
Hospital Universitario de Jerez
Jerez de la Frontera, Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, Spain
Hospital Central de La Defensa Gómez Ulla
Madrid, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Clínico San Carlos
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Infanta Sofía
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Sureste, Arganda del Rey
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Complejo Hospitalario Universitario de Ourense
Ourense, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Quironsalud Palmaplanas
Palma de Mallorca, Spain
Complejo Hospitalario de Navarre
Pamplona, Spain
Complejo Hospitalario de Pontevedra
Pontevedra, Spain
Hospital Universitario de Canarias, La Laguna
Santa Cruz de Tenerife, Spain
Hospital Universitario Nuestra Señora Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Complejo Hospitalario Universitario de Santiago
Santiago, Spain
Hospital Público Comarcal de la Merced
Seville, Spain
Hospital Universitario Virgen de la Macarena
Seville, Spain
Hospital Universitario Virgen de Valme
Seville, Spain
Hospital Virgen de la Salud
Toledo, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Hospital Universitari de Vic (Consorci Hospitalari de Vic)
Vic, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Univeritario Miguel Servet
Zaragoza, Spain
Related Publications (2)
Torre-Cisneros J, Almirante B, Martos CF, Rascado P, Lleti MS, Sanchez-Garcia M, Soriano A, Soriano-Cuesta MC, Gonzalez Calvo AJ, Karas A, Sarda J, Verardi S, Ferrer R. Effectiveness and safety of cefiderocol treatment in patients with Gram-negative bacterial infections in Spain in the early access programme: results of the PERSEUS study. Eur J Clin Microbiol Infect Dis. 2025 Jun;44(6):1375-1390. doi: 10.1007/s10096-025-05108-6. Epub 2025 Mar 25.
PMID: 40131647DERIVEDTorre-Cisneros J, Ferrer R, Martos CF, Sarda J, Gonzalez Calvo AJ, Verardi S, Karas A, Soriano A. Cefiderocol treatment for patients infected by Stenotrophomonas maltophilia, Burkholderia cepacia complex and Achromobacter spp.: subgroup analysis from the PERSEUS study. Eur J Clin Microbiol Infect Dis. 2025 Jun;44(6):1367-1374. doi: 10.1007/s10096-025-05109-5. Epub 2025 Mar 24.
PMID: 40126766DERIVED
Biospecimen
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.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 29, 2023
Study Start
July 31, 2022
Primary Completion
June 16, 2023
Study Completion
June 16, 2023
Last Updated
June 26, 2023
Record last verified: 2023-06