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Gram-Negative InfectionPERSEUSNCT05789199

Use of Cefiderocol in the Management of Gram-Negative Infections

An observational study of Gram-Negative Infection, run by Shionogi at 55 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gram-Negative Infection
What is being tested?
Cefiderocol
How many people
314 participants
Where
55 sitesSpain
Study dates
31 Jul 2022to 16 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Participants treated with cefiderocol for GNIs through the EAP in Spain.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

Spain55 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Complejo Hospitalario Universitario de Albacete

    Albacete

  • Hospital General Universitario de Alicante Doctor Balmis

    Alicante

  • Hospital Universitario de Torrevieja

    Alicante

  • Hospital Universitario San Juan de Alicante

    Alicante

  • Hospital Vega Baja de Orihuela

    Alicante

  • Hospital Universitario Torrecardenas, Almeria

    Almería

  • Hospital Universitari Germans Trias i Pujol

    Badalona

  • Hospital Clínic i Provincial de Barcelona

    Barcelona

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario de Cruces

    Bilbao

  • Hospital Universitario de Burgos

    Burgos

  • Hospital General Universitario de Ciudad Real

    Ciudad Real

  • Hospital Universitario Reina Sofía

    Córdoba

  • Hospital General Universitario de Elche

    Elche

  • Hospital Universitari de Girona Doctor Josep Trueta

    Girona

  • Hospital Universitario Virgen de las Nieves

    Granada

  • Hospital Universitario de Guadalajara, Guadalajara

    Guadalajara

  • Complejo Hospitalario de Jaén

    Jaén

  • Hospital Universitario de Jerez

    Jerez de la Frontera

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria

  • Hospital Central de La Defensa Gómez Ulla

    Madrid

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Clínico San Carlos

    Madrid

  • Hospital Universitario de La Princesa

    Madrid

  • Hospital Universitario Fundación Alcorcón

    Madrid

  • Hospital Universitario Infanta Leonor

    Madrid

  • Hospital Universitario Infanta Sofía

    Madrid

  • Hospital Universitario La Paz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Universitario Ramón y Cajal

    Madrid

  • Hospital Universitario Sureste, Arganda del Rey

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia

  • Complejo Hospitalario Universitario de Ourense

    Ourense

  • Hospital Universitari Son Espases

    Palma de Mallorca

  • Quironsalud Palmaplanas

    Palma de Mallorca

  • Complejo Hospitalario de Navarre

    Pamplona

  • Complejo Hospitalario de Pontevedra

    Pontevedra

  • Hospital Universitario de Canarias, La Laguna

    Santa Cruz de Tenerife

  • Hospital Universitario Nuestra Señora Candelaria

    Santa Cruz de Tenerife

  • Hospital Universitario Marqués de Valdecilla

    Santander

  • Complejo Hospitalario Universitario de Santiago

    Santiago

  • Hospital Público Comarcal de la Merced

    Seville

  • Hospital Universitario Virgen de la Macarena

    Seville

  • Hospital Universitario Virgen de Valme

    Seville

  • Hospital Virgen de la Salud

    Toledo

  • Hospital Clínico Universitario de Valencia

    Valencia

  • Hospital Universitari i Politecnic La Fe

    Valencia

  • Hospital Universitari de Vic (Consorci Hospitalari de Vic)

    Vic

  • Hospital Álvaro Cunqueiro

    Vigo

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza

  • Hospital Univeritario Miguel Servet

    Zaragoza

Other trials in Spain

About this study

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)

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.

Read the 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.

Being tested
Cefiderocol
Keywords
Cefiderocol, Early Access Program, Spain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CefiderocolDrug

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

Study groups in NCT05789199
Study groupRoleWhat they receive
Cefiderocol TreatedParticipants who have been treated with at least 72 hours of cefiderocol through the EAP in Spain.
Receives: Drug: Cefiderocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: From Day 1 (cefiderocol initiation) through Day 28

Secondary outcomes (10)

  1. Number of Participants Experiencing Resolution of Infection or Clinical Cure After Treatment With Cefiderocol

    Measured: Day 1 (cefiderocol initiation), every 7 days up to Day 28

  2. In-hospital Length of Stay

    Length of stay in hospital (days) for participants with infections treated by cefiderocol will be reported.

    Measured: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)

  3. Length of Stay in Intensive Care Unit (ICU)

    Length of stay in ICU (days) for participants with infections treated by cefiderocol will be reported.

    Measured: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)

  4. Length of Invasive Ventilation

    Length of invasive ventilation (days) for participants with infections treated by cefiderocol will be reported.

    Measured: Day 1 (cefiderocol initiation) up to Day 28, death, or discharge (whichever occurs first)

  5. All-cause In-hospital Mortality

    All-cause in-hospital mortality will be reported after cefiderocol initiation.

    Measured: Day 14, Day 28

  6. Cause of Death

    The relation of death to the reference infection, as reported in the medical notes, will be reported.

    Measured: Day 1 (cefiderocol initiation) through Day 28

  7. 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.

    Measured: Day 1 (24 hours post cefiderocol initiation) through Day 28

  8. 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.

    Measured: Day 1 (cefiderocol initiation) through Day 28

  9. 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.

    Measured: Up to 28 days post-treatment completion with cefiderocol, death, or discharge (whichever occurs first)

  10. Number of Participants Experiencing Resolution of Infection or Clinical Cure After Prolonged Treatment With Cefiderocol

    Measured: Day 1 (cefiderocol initiation), every 10 days up to Day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2023
  2. Study start31 Jul 2022
  3. Primary completion16 Jun 2023
  4. Study completion16 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
314 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05789199
Sponsor's protocol ID
2020-266-4
Acronym
PERSEUS
Status last verified
Jun 2023
First submitted
16 Feb 2023
Last updated
26 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40131647

  • 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.

    PubMed 40126766

Questions about this trial

What is this clinical trial studying?

An observational study of Gram-Negative Infection, run by Shionogi at 55 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate Of Clinical Success (time frame: From Day 1 (cefiderocol initiation) through Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05789199, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.

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