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Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis

NCT05314764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cefiderocol

Patients will receive intravenous cefiderocol every 6 to 8 hours for 4 to 6 doses.

Sponsors & Collaborators

  • Shionogi Inc.

    collaborator INDUSTRY

  • Keystone Bioanalytical, Inc.

    collaborator UNKNOWN

  • Indiana University Health Methodist Hospital

    collaborator OTHER

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Joseph L Kuti, PharmD · Hartford Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-06-01
Completion
2024-12-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05314764 on ClinicalTrials.gov