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Use of Cefiderocol in the Management of Gram-Negative Infections

NCT ID: NCT05789199

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

314 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-31

Study Completion Date

2023-06-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Gram-Negative Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cefiderocol Treated

Participants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.

Cefiderocol

Intervention Type DRUG

Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.

Interventions

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Cefiderocol

Cefiderocol is a novel siderophore cephalosporin developed for the treatment of infections caused by Gram-negative bacteria (GNB), including those resistant to carbapenems.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shionogi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status

Complejo Hospitalario Universitario de Albacete

Albacete, , Spain

Site Status

Hospital General Universitario de Alicante Doctor Balmis

Alicante, , Spain

Site Status

Hospital Universitario de Torrevieja

Alicante, , Spain

Site Status

Hospital Universitario San Juan de Alicante

Alicante, , Spain

Site Status

Hospital Vega Baja de Orihuela

Alicante, , Spain

Site Status

Hospital Universitario Torrecardenas, Almeria

Almería, , Spain

Site Status

Hospital Universitari Germans Trias i Pujol

Badalona, , Spain

Site Status

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario de Cruces

Bilbao, , Spain

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital General Universitario de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital General Universitario de Elche

Elche, , Spain

Site Status

Hospital Universitari de Girona Doctor Josep Trueta

Girona, , Spain

Site Status

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status

Hospital Universitario de Guadalajara, Guadalajara

Guadalajara, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Hospital Universitario de Jerez

Jerez de la Frontera, , Spain

Site Status

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, , Spain

Site Status

Hospital Central de La Defensa Gómez Ulla

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario de La Princesa

Madrid, , Spain

Site Status

Hospital Universitario Fundación Alcorcón

Madrid, , Spain

Site Status

Hospital Universitario Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario Infanta Sofía

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Universitario Sureste, Arganda del Rey

Madrid, , Spain

Site Status

Hospital Regional Universitario de Málaga

Málaga, , Spain

Site Status

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, , Spain

Site Status

Complejo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status

Hospital Universitari Son Espases

Palma de Mallorca, , Spain

Site Status

Quironsalud Palmaplanas

Palma de Mallorca, , Spain

Site Status

Complejo Hospitalario de Navarre

Pamplona, , Spain

Site Status

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Site Status

Hospital Universitario de Canarias, La Laguna

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitario Nuestra Señora Candelaria

Santa Cruz de Tenerife, , Spain

Site Status

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status

Complejo Hospitalario Universitario de Santiago

Santiago, , Spain

Site Status

Hospital Público Comarcal de la Merced

Seville, , Spain

Site Status

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

Hospital Virgen de la Salud

Toledo, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status

Hospital Universitari de Vic (Consorci Hospitalari de Vic)

Vic, , Spain

Site Status

Hospital Álvaro Cunqueiro

Vigo, , Spain

Site Status

Hospital Clinico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

Hospital Univeritario Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40131647 (View on PubMed)

Torre-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.

Reference Type DERIVED
PMID: 40126766 (View on PubMed)

Other Identifiers

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2020-266-4

Identifier Type: -

Identifier Source: org_study_id

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