Clinical trial NCT05789199: Use of Cefiderocol in the Management of Gram-Negative Infections
Official title: Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram-Negative Infection
Keywords: Cefiderocol
Early Access Program
Spain
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants treated with cefiderocol for GNIs through the EAP in Spain.

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.

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.

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.

Primary outcomes:
measure: Rate Of Clinical Success
timeFrame: From Day 1 (cefiderocol initiation) through Day 28
Secondary outcomes:
measure: Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol
timeFrame: Day 1 (cefiderocol initiation), every 7 days up to Day 28
measure: In-hospital Length of Stay
timeFrame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
measure: Length of Stay in Intensive Care Unit (ICU)
timeFrame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
measure: Length of Invasive Ventilation
timeFrame: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
measure: All-cause In-hospital Mortality
timeFrame: Day 14, Day 28
measure: Cause of Death
timeFrame: Day 1 (cefiderocol initiation) through Day 28
measure: Rate of Microbiological Eradication
timeFrame: Day 1 (24 hours post cefiderocol initiation) through Day 28
measure: Severity of Illness
timeFrame: Day 1 (cefiderocol initiation) through Day 28
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first)
measure: Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol
timeFrame: Day 1 (cefiderocol initiation), every 10 days up to Day 60
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Doctor Balmis
city: Alicante
country: Spain
facility: Hospital Universitario de Torrevieja
city: Alicante
country: Spain
facility: Hospital Universitario San Juan de Alicante
city: Alicante
country: Spain
facility: Hospital Vega Baja de Orihuela
city: Almeria
country: Spain
facility: Hospital Universitario Torrecardenas, Almeria
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara, Guadalajara
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
city: Jerez de la Frontera
country: Spain
facility: Hospital Universitario de Jerez
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrín
city: Madrid
country: Spain
facility: Hospital Central de La Defensa Gómez Ulla
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Alcorcón
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Sofía
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Sureste, Arganda del Rey
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
city: Palma de Mallorca
country: Spain
facility: Quironsalud Palmaplanas
city: Pamplona
country: Spain
facility: Complejo Hospitalario de Navarre
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias, La Laguna
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora Candelaria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Santiago
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Público Comarcal de la Merced
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Vic
country: Spain
facility: Hospital Universitari de Vic (Consorci Hospitalari de Vic)
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Univeritario Miguel Servet
Study officials:
References: