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NCT05314764 · ClinicalTrials.gov registry record · Phase 4
Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis
A Phase 4 study, sponsored by Hartford Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
NCT05314764 is a Phase 4 study that has completed, run by Hartford Hospital. The registered enrollment target is 10 participants.
The verdict
NCT05314764, a Phase 4 study, has completed, sponsored by Hartford Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
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.
Interventions
- DRUG Cefiderocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2024-12-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05314764
The ClinicalTrials.gov registry entry for NCT05314764 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hartford Hospital, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cefiderocol is the first listed.
NCT05314764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05314764 about?
NCT05314764 is a clinical study titled "Cefiderocol Pharmacokinetics in Adult Patients With Cystic Fibrosis". 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 multidru...
What is the current status of trial NCT05314764?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2022-06-01. Estimated completion is 2024-12-11.
What interventions are being tested in trial NCT05314764?
The interventions under investigation include: Cefiderocol (DRUG).
Who is sponsoring clinical trial NCT05314764?
This trial is sponsored by Hartford Hospital, which has 75 total clinical trials registered on ClinicalTrials.gov.
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