Evidence map›Paper›PMID 40131647›Full record

ArticleEuropean journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology2025

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.

Julian Torre-Cisneros, Benito Almirante, Carmen De La Fuente Martos, Pedro Rascado, Miguel Salavert Lletí, Miguel Sánchez-García, Alex Soriano, Maria Cruz Soriano-Cuesta, A Javier Gonzalez Calvo, Andreas Karas and 3 more

Registry-linked trialAbstract readMulticenter Study
In one paragraph

Article in European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05789199 (Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05789199 completednot on this map

Retrospective Analysis of Real-World Use of Cefiderocol in the Management of Gram-Negative Infections as Part of the Early Access Program (PERSEUS Study)

TypeobservationalSponsorShionogiRan2022 to 2023Enrolled314ConditionsGram-Negative InfectionArmsCefiderocol
3 · Its place in the literature

Who cites it

21 citing papers in PubMed.

  1. ASP-COMPLEX: redefining antimicrobial stewardship to improve outcomes in high-risk patients with severe infections.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  2. Challenges and opportunities in the management of severe pneumonia. Key concepts from the Seventh Annual Meeting of Spanish Experts 2025.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Metallo-β-lactamase-producingFrontiers in microbiology · 2026
    Review
  10. Review
  11. New Antibiotics Against Multidrug-Resistant Gram-Negative Bacteria in Lung Transplantation: Clinical Evidence, Safety, and PK/PD Properties.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  12. Review
  13. Review
  14. Review
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  16. Therapeutic optimization against bacteria carrying metalloenzymes: the battle for class B.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Review
  17. Therapeutic approach in the critically ill patient with suspected multidrug resistance.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Review
  18. Therapeutic management of health care-associated pneumonia.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2025
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Julian Torre-CisnerosMaimónides Biomedical Research Institute of Córdoba (IMIBIC), Reina Sofia University Hospital of Córdoba, Córdoba, Spain.
Benito AlmiranteCentro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Carmen De La Fuente MartosMaimónides Biomedical Research Institute of Córdoba (IMIBIC), Reina Sofia University Hospital of Córdoba, Córdoba, Spain.
Pedro RascadoIntensive Care Unit, Complejo Hospitalario Universitario Santiago de Compostela, Santiago de Compostela, Spain.
Miguel Salavert LletíInfectious Diseases Unit, Medical Clinic Department, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
Miguel Sánchez-GarcíaCritical Care Department, Hospital Clínico San Carlos, Universidad Complutense, Madrid, Spain.
Alex SorianoCentro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Maria Cruz Soriano-CuestaIntensive Care Medicine Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
A Javier Gonzalez CalvoShionogi SLU, Calle de Serrano 45, Madrid, 28001, Spain.
Andreas KarasShionogi BV, London, UK.
Jessica SardaShionogi SLU, Calle de Serrano 45, Madrid, 28001, Spain. jessica.sarda@shionogi.eu.
Stefano VerardiShionogi BV, London, UK.
Ricard FerrerIntensive Care Department, SODIR Reseach Group, Vall d'Hebron Institut de Recerca, Hospital Universitari Vall d'Hebrón, Universitat Autònoma de Barcelona, Barcelona, Spain.

Funding

Shionogi NA
6 · The paper itself

Abstract

purposeWe assessed the effectiveness and safety of cefiderocol in patients with Gram-negative bacterial infections, excluding Acinetobacter spp., in the early access programme (EAP) in Spain.

methodsThe retrospective, multicentre PERSEUS study (2018-2022) enrolled hospitalised patients with serious Gram-negative infections, except Acinetobacter spp., who received first-time cefiderocol for ≥ 72 h following requests through the EAP. Clinical cure at end of treatment, all-cause mortality at Day 28, cefiderocol use, and adverse drug reactions (ADRs) were the key outcomes.

resultsOverall, 261 patients were eligible for analysis. Median (interquartile range) age was 61 (49-68) years, 202 (77.4%) were male and 165 (63.2%) were in the intensive care unit. The most frequent diagnoses were respiratory tract infection (47.9%), intra-abdominal infection (14.6%), and urinary tract infection (14.6%). The median (IQR) duration of cefiderocol treatment was 10 (7-14) days. Overall, the clinical cure rate was 80.5% (210/261) and the 28-day mortality rate was 21.5% (56/261). In patients with Pseudomonas aeruginosa infection (66.7% [n = 174], including 73 [42%] with metallo-β-lactamases), the clinical cure rate was 84.5% (147/174) and the 28-day mortality was 17.2% (30/174). Logistic regression analysis showed that prior antibiotic treatment for > 7 days (OR 0.19, 95% CI 0.05-0.56) and mechanical ventilation (OR 0.32, 95% CI 0.15-0.67) were independent negative predictive factors for clinical cure. ADRs occurred in seven patients, six events resolved, and one was fatal (toxic epidermal necrolysis).

conclusionsCefiderocol is a valuable option in the treatment of serious Gram-negative bacterial infections, particularly for those caused by P. aeruginosa. CLINICALTRIALS: GOV: NCT05789199 (Registration date: 16 February 2023).

Indexed as

Anti-Bacterial AgentsCefiderocolCephalosporinsGram-Negative Bacterial InfectionsAgedFemaleGram-Negative BacteriaHumansIntraabdominal InfectionsMaleMiddle AgedRetrospective StudiesSpainTreatment OutcomeAnti-Bacterial AgentsCefiderocolCephalosporinsCarbapenem resistanceCefiderocolEarly appropriate therapyGram-negativeLimited treatment optionsMultidrug resistancePseudomonas aeruginosa

Identifiers

PMID40131647
PMCPMC12116923

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.