Status:
COMPLETED
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
Lead Sponsor:
Hartford Hospital
Collaborating Sponsors:
Shionogi Inc.
Keystone Bioanalytical, Inc.
Conditions:
Cystic Fibrosis
Pneumonia, Bacterial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 i...
Detailed Description
Participants will receive 4-6 doses of cefiderocol 2 grams every 6-8 hours, in addition to standard intravenous antibiotic therapy selected by the site. Just prior and then after the final dose, a tot...
Eligibility Criteria
Inclusion
- Documented diagnosis of CF
- Acute pulmonary exacerbation as the primary reason for admission to the hospital with requirement to receive systemic antibiotic treatment
Exclusion
- Females that are pregnant and/or breastfeeding
- History of any moderate or severe hypersensitivity or allergic reaction to any β-lactam antibiotic (a history of mild rash to a cephalosporin followed by uneventful re-exposure is not a contraindication)
- History of a lung transplant at any time in the past or any other organ transplantation (e.g., liver) within the last 6 months
- Moderate to severe renal dysfunction defined as a creatinine clearance \< 60 mL/min (as calculated by the Cockcroft-Gault equation using actual body weight) or requirement for continuous renal replacement therapy or hemodialysis
- A hemoglobin less than 8 gm/dL at baseline
- Any rapidly-progressing disease or immediately life-threatening illness (defined as imminent death within 48 hours in the opinion of the investigator)
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05314764
Start Date
June 1 2022
End Date
December 11 2024
Last Update
December 16 2024
Active Locations (4)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06106
2
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
3
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
4
UT Southwestern Clements University Hospital
Dallas, Texas, United States, 75390