Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
There is established evidence that adult patients with Cystic Fibrosis (CF) may have altered
antibiotic pharmacokinetics compared with non-CF patients. Cefiderocol is a newly approved
broad spectrum intravenous siderophore cephalosporin antibiotic, which has potent in vitro
activity against multidrug resistant Pseudomonas aeruginosa, Burkholderia cepacia complex,
Achromobacter species, and Stenotrophomonas maltophilia, all pathogens implicated in CF
pulmonary exacerbations. This study will determine the pharmacokinetics and tolerability of
cefiderocol in 12 adult CF patients admitted for a pulmonary exacerbation at one of 4
participating hospitals in the US. Patients will remain on standard of care IV antibiotics
and receive 4-6 doses of cefiderocol 2 grams infused over 3 hours every 6-8 hours, depending
on kidney function. Blood will be sampled after the final dose to determine concentrations
and pharmacokinetics of cefiderocol. Safety and tolerability will be assessed throughout the
2 day study.
Phase:
Phase 4
Details
Lead Sponsor:
Hartford Hospital
Collaborators:
Indiana University Health Methodist Hospital Keystone Bioanalytical, Inc. Shionogi Inc. University of Pittsburgh Medical Center University of Texas