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)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Fetroja
• Medical condition to be studied:
  Bacterial infection

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  Describe how cefiderocol is used in patients with documented gram-negative bacterial infections
• Outcomes:
  Characteristics of patients placed on cefiderocol, description of types of infections: sites, severity, pathogen, and resistance patterns, how cefiderocol is used (dose, frequency, and how used with other antibiotics. Clinical resolution including all-cause mortality, length of stay. Adverse events associated with cefiderocol use. Above primary outcomes stratified by carbapenem resistance status, specific pathogens, and infection sites, potential risk factors for carbapenem resistance, time to clinical cure, pattern of overall antibiotic treatments before, after, during the use of cefiderocol, hospital resource use after infection onset.
• Data analysis plan:
  This is a descriptive study and most measurements will be summary measures of central tendency with confidence intervals and/or quartile measurement where appropriate. Where trends are seen among ordered categories, tests of trends will be used For predictors of carbapenem resistance, logistic regression will be used with the odds ratio as the primary measure of association. For linear predictors, linear regression may be employed.