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  3. 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

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

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Torre-Cisneros J.
  • Almirante B.
  • Martos C.D.L.F.
  • Rascado P.
  • Sánchez-García M.
  • Soriano A.
  • Soriano-Cuesta M.C.
  • Gonzalez Calvo A.J.
  • Karas A.
  • Sarda J.
  • Verardi S.
  • Ferrer R.

Grupos

Abstract

Purpose: We 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. Methods: The 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. Results: Overall, 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-ß-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). Conclusions: Cefiderocol 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). © The Author(s) 2025.

Datos de la publicación

ISSN/ISSNe:
0934-9723, 1435-4373

EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES  SPRINGER

Tipo:
Article
Páginas:
1375-1390
PubMed:
40131647
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
1,205 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • Aged; Anti-Bacterial Agents; Cefiderocol; Cephalosporins; Female; Gram-Negative Bacteria; Gram-Negative Bacterial Infections; Humans; Intraabdominal Infections; Male; Middle Aged; Retrospective Studies; Spain; Treatment Outcome; cefiderocol; metallo beta lactamase; antiinfective agent; cefiderocol; cephalosporin derivative; abdominal infection; adult; aged; all cause mortality; antibiotic therapy; Article; artificial ventilation; clinical effectiveness; clinical outcome; female; Gram negative infection; health care access; hospital patient; human; major clinical study; male; medical record review; mortality rate; multicenter study; patient safety; Pseudomonas infection; respiratory tract infection; retrospective study; Spain; urinary tract infection; clinical trial; drug effect; drug therapy; epidemiology; Gram negative bacterium; Gram negative infection; microbiology; middle aged; mortality; treatment outcome

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