# P-1352. Clinical Outcomes of Cefiderocol for Treatment of Bloodstream Infections Caused by Gram-Negative Bacteria: Subgroup Analysis of the PROVE Study

## TL;DR

This study evaluates the effectiveness of cefiderocol in treating bloodstream infections caused by Gram-negative bacteria in hospitalized patients.

## Contribution

The study provides real-world clinical outcomes of cefiderocol for Gram-negative bloodstream infections in a large international cohort.

## Key findings

- The overall clinical cure rate was 63.7%, with higher cure rates for primary compared to secondary bloodstream infections.
- 30-day all-cause mortality was 24.8%, with secondary BSIs showing higher mortality than primary BSIs.
- Cefiderocol showed high cure rates for Pseudomonas aeruginosa and Stenotrophomonas maltophilia bloodstream infections.

## Abstract

Bloodstream infections (BSIs) are associated with increased morbidity and mortality. In this subgroup analysis of the PROVE study, the clinical outcomes of hospitalized patients with BSIs caused by Gram-negative bacteria, who were treated with cefiderocol, were evaluated.

In the international, observational PROVE chart review study, hospitalized patients with confirmed Gram-negative bacterial infections were treated with cefiderocol in routine practice for the first time for ≥72 hours (November 2020–July 2024). In this analysis, data of patients with primary or secondary BSIs were analyzed. Baseline demographics, clinical characteristics, cefiderocol use, clinical cure, clinical response, and all-cause mortality (ACM) rates were evaluated.

BSI was reported in 226 patients (primary: 47.8%; secondary: 52.2%). The median (interquartile range [IQR]) age was 60 (46–69) years and 58.8% were male (Table 1). Diabetes mellitus was the most common concomitant condition (27.9%), followed by chronic pulmonary disease (18.6%) and sepsis or septic shock (18.1%). The median (IQR) duration of cefiderocol treatment was 12 (8.0–16.0) days. At cefiderocol initiation, 55.3% of patients were in the intensive care unit and 46.0% were receiving organ support. Overall, the clinical cure rate was 63.7% (primary BSIs: 68.5%; secondary BSIs: 59.3%) and 30-day ACM was 24.8% (primary BSIs: 19.4%; secondary BSIs: 29.7%) (Table 2). Of 81 patients with monomicrobial Pseudomonas aeruginosa BSI, 72.8% had clinical cure. The clinical cure rates in patients with monomicrobial BSIs caused by Enterobacterales species, Acinetobacter baumannii, and Stenotrophomonas maltophilia were 57.4%, 55.3%, and 83.3%, respectively. Polymicrobial BSIs were reported in 35 patients, with clinical cure and 30-day ACM rates of 60.0% and 22.9%, respectively.

In this large cohort of cefiderocol-treated patients, secondary BSIs were associated with more frequent treatment failure compared with primary BSIs, suggesting that patients with secondary BSIs may require more aggressive antibiotic treatment.

David W. Wareham, MD, MRCP, FRCPath, Antimicrobial Research UK: Grant/Research Support|Rosetrees UK: Grant/Research Support Massimo Antonelli, MD, Fisher & Paykel Healthcare: Grant/Research Support|GE Healthcare: Grant/Research Support|Menarini: Advisor/Consultant|Pfizer: Advisor/Consultant|Shionogi BV: Advisor/Consultant Stefano Verardi, MD, Shionogi BV: Employee Karan Gill, Master of Science, Shionogi BV: Employee Anne Santerre Henriksen, PHD, Shionogi BV: Advisor/Consultant Sean T. Nguyen, PharmD, Shionogi Inc: Employee