Journal Article
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; Jessica Sarda; Stefano Verardi; Ricard Ferrer
European Journal of Clinical Microbiology & Infectious Diseases · Vol. 44, Issue 6 · pp. 1375-1390 · 2025
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-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). 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).