Use of Cefiderocol in the Management of Gram-Negative Infections

Gram-Negative Infection Clinical Trial

— PERSEUS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05789199
• Other study ID #: 2020-266-4
• Status: Completed
• Start date: July 31, 2022
• Est. completion date: June 16, 2023

Study information

• Verified date: June 2023
• Source: Shionogi Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: June 16, 2023
• Est. primary completion date: June 16, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Gram-Negative Infection
• Infections

Intervention

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

Locations

Country	Name	City	State
Spain	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	Almeria
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	Jaen
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	Sevilla
Spain	Hospital Universitario Virgen de la Macarena	Sevilla
Spain	Hospital Universitario Virgen de Valme	Sevilla
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

Sponsors (1)

Lead Sponsor	Collaborator
Shionogi

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	In-hospital Length of Stay	Length of stay in hospital (days) for participants with infections treated by cefiderocol will be reported.	Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Secondary	Length of Stay in Intensive Care Unit (ICU)	Length of stay in ICU (days) for participants with infections treated by cefiderocol will be reported.	Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Secondary	Length of Invasive Ventilation	Length of invasive ventilation (days) for participants with infections treated by cefiderocol will be reported.	Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)
Secondary	All-cause In-hospital Mortality	All-cause in-hospital mortality will be reported after cefiderocol initiation.	Day 14, Day 28
Secondary	Cause of Death	The relation of death to the reference infection, as reported in the medical notes, will be reported.	Day 1 (cefiderocol initiation) through Day 28
Secondary	Rate of Microbiological Eradication	The rate of eradication of carbapenem-resistant GNIs will be reported as the percent microbiological eradication among participants with blood stream infections (BSIs) and complicated urinary tract infections (cUTIs)/UTIs from 24 hours of cefiderocol initiation until Day 28. BSI microbiological eradication will be defined as the absence of a positive follow-up blood culture, in which the same organism as the initial blood culture was obtained. Any positive blood cultures drawn within 24 hours of the initial positive culture will be considered as the same episode. cUTI/UTI microbiological eradication will be defined as an absence of a positive follow-up culture of the same organism as the initial infection obtained.	Day 1 (24 hours post cefiderocol initiation) through Day 28
Secondary	Severity of Illness	The severity of illness at the time of cefiderocol administration at baseline will be described by a Sequential Organ Failure Assessment (SOFA) Score, quickSOFA (qSOFA) score, level of organ support, and presence of septic shock. The SOFA score for participants in ICU or qSOFA score for participants outside ICU will be reported for days -3, 0, and 7 in relation to the date of cefiderocol initiation.	Day 1 (cefiderocol initiation) through Day 28
Secondary	Number of Participants With Adverse Drug Reactions (ADRs)	The number of participants with serious and non-serious adverse events with explicit attribution to cefiderocol (ADR) will be reported.	Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first)
Secondary	Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol		Day 1 (cefiderocol initiation), every 10 days up to Day 60