PROVE

PROVE

A retrospective chart review study of cefiderocol real world outcomes and safety in the treatment of patients with Gram-negative bacterial infections (GNBI) in the US and Europe PROVE (Retrospective Cefiderocol Chart Review Study) 

The study intends to understand the clinical characteristics, cefiderocol use, other antibiotics use, microbiology, outcomes and safety of patients treated with cefiderocol for the indicated GNBI (defined as the documented GNBI that prompted the cefiderocol use). 

Primary Objective:
• To describe the clinical characteristics (comorbidity, underlying disease admission diagnosis) and microbiology characteristics (pathogens, susceptibility results including MIC to cefiderocol) characteristics, outcomes, and safety of patients treated with cefiderocol

Secondary Objectives:
• To describe how cefiderocol was used, including infection sites and its dosing regimen
• To describe the overall in-hospital mortality of patients and by specific pathogen
• To describe clinical outcomes of the indicated GNBI after cefiderocol treatment
• To describe the number and type of adverse events related to cefiderocol
• To describe the patient population characteristics treated with cefiderocol

Please use this link for further information:
clinicaltrials.gov


Primary Investigator: John Cafardi