PERSEUS: Use of Cefiderocol in the Management of Gram-Negative Infections

Sponsor

Shionogi (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05789199

Collaborator

(none)

250

Enrollment

Locations

Anticipated Duration (Months)

4.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gram-Negative Infection	Drug: Cefiderocol

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Jul 31, 2022

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cefiderocol Treated Participants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.	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.

Arm

Intervention/Treatment

Cefiderocol Treated

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

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.

Outcome Measures

Primary Outcome Measures

Rate Of Clinical Success [From Day 1 (cefiderocol initiation) through Day 28]
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).

Secondary Outcome Measures

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 hospital (days) for participants with infections treated by cefiderocol will be reported.
Length of Stay in Intensive Care Unit (ICU) [Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)]
Length of stay in ICU (days) for participants with infections treated by cefiderocol will be reported.
Length of Invasive Ventilation [Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)]
Length of invasive ventilation (days) for participants with infections treated by cefiderocol will be reported.
All-cause In-hospital Mortality [Day 14, Day 28]
All-cause in-hospital mortality will be reported after cefiderocol initiation.
Cause of Death [Day 1 (cefiderocol initiation) through Day 28]
The relation of death to the reference infection, as reported in the medical notes, will be reported.
Rate of Microbiological Eradication [Day 1 (24 hours post cefiderocol initiation) through Day 28]
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.
Severity of Illness [Day 1 (cefiderocol initiation) through Day 28]
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.
Number of Participants With Adverse Drug Reactions (ADRs) [Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first)]
The number of participants with serious and non-serious adverse events with explicit attribution to cefiderocol (ADR) will be reported.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	Country
1	Complejo Hospitalario Universitario A Coruña	A Coruña	Spain
2	Complejo Hospitalario Universitario de Albacete	Albacete	Spain
3	Hospital General Universitario de Alicante Doctor Balmis	Alicante	Spain
4	Hospital Universitario de Torrevieja	Alicante	Spain
5	Hospital Universitario San Juan de Alicante	Alicante	Spain
6	Hospital Vega Baja de Orihuela	Alicante	Spain
7	Hospital Universitario Torrecardenas, Almeria	Almeria	Spain
8	Hospital Universitari Germans Trias i Pujol	Badalona	Spain
9	Hospital Clínic i Provincial de Barcelona	Barcelona	Spain
10	Hospital Universitari de Bellvitge	Barcelona	Spain
11	Hospital Universitari Vall d'Hebron	Barcelona	Spain
12	Hospital Universitario de Cruces	Bilbao	Spain
13	Hospital Universitario de Burgos	Burgos	Spain
14	Hospital General Universitario de Ciudad Real	Ciudad Real	Spain
15	Hospital Universitario Reina Sofía	Córdoba	Spain
16	Hospital General Universitario de Elche	Elche	Spain
17	Hospital Universitari de Girona Doctor Josep Trueta	Girona	Spain
18	Hospital Universitario Virgen de las Nieves	Granada	Spain
19	Hospital Universitario de Guadalajara, Guadalajara	Guadalajara	Spain
20	Complejo Hospitalario de Jaén	Jaen	Spain
21	Hospital Universitario de Jerez	Jerez de la Frontera	Spain
22	Hospital Universitario de Gran Canaria Doctor Negrín	Las Palmas de Gran Canaria	Spain
23	Hospital Central de La Defensa Gómez Ulla	Madrid	Spain
24	Hospital General Universitario Gregorio Marañón	Madrid	Spain
25	Hospital Universitario 12 de Octubre	Madrid	Spain
26	Hospital Universitario Clínico San Carlos	Madrid	Spain
27	Hospital Universitario de La Princesa	Madrid	Spain
28	Hospital Universitario Fundación Alcorcón	Madrid	Spain
29	Hospital Universitario Infanta Leonor	Madrid	Spain
30	Hospital Universitario Infanta Sofía	Madrid	Spain
31	Hospital Universitario La Paz	Madrid	Spain
32	Hospital Universitario Puerta de Hierro	Madrid	Spain
33	Hospital Universitario Ramón y Cajal	Madrid	Spain
34	Hospital Universitario Sureste, Arganda del Rey	Madrid	Spain
35	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia	Spain
36	Hospital Regional Universitario de Málaga	Málaga	Spain
37	Complejo Hospitalario Universitario de Ourense	Ourense	Spain
38	Hospital Universitari Son Espases	Palma de Mallorca	Spain
39	Quironsalud Palmaplanas	Palma de Mallorca	Spain
40	Complejo Hospitalario de Navarre	Pamplona	Spain
41	Complejo Hospitalario de Pontevedra	Pontevedra	Spain
42	Hospital Universitario de Canarias, La Laguna	Santa Cruz de Tenerife	Spain
43	Hospital Universitario Nuestra Señora Candelaria	Santa Cruz de Tenerife	Spain
44	Hospital Universitario Marqués de Valdecilla	Santander	Spain
45	Complejo Hospitalario Universitario de Santiago	Santiago	Spain
46	Hospital Público Comarcal de la Merced	Sevilla	Spain
47	Hospital Universitario Virgen de la Macarena	Sevilla	Spain
48	Hospital Universitario Virgen de Valme	Sevilla	Spain
49	Hospital Virgen de la Salud	Toledo	Spain
50	Hospital Clínico Universitario de Valencia	Valencia	Spain
51	Hospital Universitari i Politecnic La Fe	Valencia	Spain
52	Hospital Universitari de Vic (Consorci Hospitalari de Vic)	Vic	Spain
53	Hospital Álvaro Cunqueiro	Vigo	Spain
54	Hospital Clinico Universitario Lozano Blesa	Zaragoza	Spain
55	Hospital Univeritario Miguel Servet	Zaragoza	Spain

Sponsors and Collaborators

Shionogi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shionogi

ClinicalTrials.gov Identifier:

NCT05789199

Other Study ID Numbers:

2020-266-4

First Posted:

Mar 29, 2023

Last Update Posted:

Mar 29, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Shionogi

Cefiderocol

Early Access Program

Spain

Additional relevant MeSH terms:

Infections

Communicable Diseases

Study Results

No Results Posted as of Mar 29, 2023