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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: Completed Phase 4 study, sponsored by Hartford Hospital.
NCT05314764 is a Phase 4 study that has completed, run by Hartford Hospital. The registered enrollment target is 10 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This outcome determines the clearance of cefiderocol over the dosing interval.
Interventions
- DRUG Cefiderocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2022-06-01 |
| Est. Completion | 2024-12-11 |
| Phase | Phase 4 |
What the finished NCT05314764 record still lists
NCT05314764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cefiderocol is the first listed.
NCT05314764 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05314764's enrollment target sits among peer trials
10 1940th of 2000 higher than 33 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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