Scholarlink

Purpose <p>We assessed the effectiveness and safety of cefiderocol in patients with Gram-negative bacterial infections, excluding <i>Acinetobacter</i> spp., in the early access programme (EAP) in Spain.</p> Methods <p>The retrospective, multicentre PERSEUS study (2018–2022) enrolled hospitalised patients with serious Gram-negative infections, except <i>Acinetobacter</i> spp., who received first-time cefiderocol for ≥ 72&#xa0;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.</p> Results <p>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 <i>Pseudomonas aeruginosa</i> infection (66.7% [<i>n</i> = 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 &gt; 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).</p> Conclusions <p>Cefiderocol is a valuable option in the treatment of serious Gram-negative bacterial infections, particularly for those caused by <i>P. aeruginosa</i>.</p> ClinicalTrials.gov <p>NCT05789199 (Registration date: 16 February 2023).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年3月25日

查看全文
  • 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

摘要

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).