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.

Autores de IIS La Fe

• Miguel Salavert Lletí

  Autor

Participantes ajenos a IIS La Fe

• Torre-Cisneros, Julian
• Almirante, Benito
• Martos, Carmen De La Fuente
• Rascado, Pedro
• Sanchez-Garcia, Miguel
• Soriano, Alex
• Soriano-Cuesta, Maria Cruz
• Gonzalez Calvo, A Javier
• Karas, Andreas
• Sarda, Jessica
• Verardi, Stefano
• Ferrer, Ricard

Grupos

• Infección Grave

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 =72h 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-beta-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).

© 2025. The Author(s).

Keywords

• Pseudomonas aeruginosa; Carbapenem resistance; Cefiderocol; Early appropriate therapy; Gram-negative; Limited treatment options; Multidrug resistance