Retrospective Cefiderocol Chart Review Study — PROVE1

Real-world evidence is intended to complement data from randomized clinical trials. Observational retrospective analyses are not intended for direct comparison with clinical trials.

US interim analysis of patients treated between November 2020 and March 2023

Study design

  • PROVE is an ongoing, multicenter, retrospective chart review study of existing medical records from patients receiving first-time cefiderocol treatment for a Gram-negative bacterial infection (GNBI)
  • Study endpoints included clinical response at the end of cefiderocol treatment; in-hospital, all-cause mortality (ACM); and safety (ie, adverse drug reactions)
  • Included patients with documented GNBI; with known infection site and species and had received first-time cefiderocol treatment lasting ≥72 hours; with known start and stop dates, dose, and duration; and documented treatment outcome and discharge status
  • Patients were excluded for incomplete data, enrollment in cefiderocol clinical trials, or use before commercial availability
  • Data are shown for 151 patients with urinary tract (n=15) and respiratory tract (n=136) infections out of the overall population (N=244) of patients in the US interim analysis
Select patient characteristics by infection site
Age ≥65 years 24.3% (33) 66.7% (10)
Gender, male 58.1% (79) 60.0% (9)
Organ support while in ICU (>10%) 66.2% (90) 20.0% (3)
Mechanical ventilation 65.4% (89) 6.7% (1)
Continuous renal replacement therapy (CRRT) 26.5% (36) 6.7% (1)
Vasopressor use 48.5% (66) 6.7% (1)
COVID-19 14.0% (19) 0.0% (0)
Antimicrobials or antifungals used prior to cefiderocol 47.1% (64) 40.0% (6)
Monomicrobial infections 70.6% (96) 73.3% (11)
Polymicrobial infections 29.4% (40) 26.7% (4)
Reason for starting cefiderocol
Empiric for suspected CR Gram-negative bacterial infection 10.3% (14) 13.3% (2)
Documented infection 75.0% (102) 73.3% (11)
Salvage treatment due to prior antibiotics failed or not treated 14.7% (20) 13.3% (2)
Time from admission to first cefiderocol dose, days (median, Q1-Q3) 20.5 (6-43) 4 (3-11)
Time from positive culture to first cefiderocol dose, days (median, Q1-Q3) 5 (3-7) 5 (3-11)
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PROVE study US interim analysis:
Real-world evidence supports efficacy data across clinical trials1

Outcomes in patients with urinary tract infections

Outcomes in patients with urinary tract infections: 93.3% (14/15) overall clinical response at EOT and 6.7% (1/15) overall 30-day ACM.

Outcomes in patients with respiratory tract infections

Outcomes in patients with respiratory tract infections: 71.3% (97/136) overall clinical response at EOT and 22.8% (31/136) overall 30-day ACM.
Clinical response at EOT is defined as patients with resolution or improvement of signs/symptoms at the end of cefiderocol treatment (EOT) as reported by the physician and who were alive at EOT, regardless of whether they had a relapse/reinfection with the same species after EOT.
  • In the overall population (N=244), 2% (n=5) of patients experienced 6 adverse drug reactions (1 diarrhea [suspected Clostridioides difficile but never confirmed], 1 diarrhea that could have been from cefiderocol or daptomycin, 1 increased liver function test, 1 rash, and 1 urticarial rash), including 1 patient who experienced a serious adverse drug reaction (interstitial nephritis, acute kidney injury)
  • Closely monitor the clinical response to therapy in patients with cUTI and HABP/VABP

EOT=end of treatment.

Real-world evidence supports Fetroja as an option for patients with Gram-negative bacterial infections and limited treatment options1