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NCT03862040 · ClinicalTrials.gov registry record · Phase 1
Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
A Phase 1 study, sponsored by Shionogi.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03862040: Clinical Trial Phase 1 study, sponsored by Shionogi.
NCT03862040 is a Phase 1 study that was terminated before completion, run by Shionogi. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03862040, a Phase 1 study, was terminated before completion, sponsored by Shionogi.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary purpose of the study is to determine the degree of penetration of cefiderocol into infected lung tissue in hospitalized adults with bacterial pneumonia who are being mechanically ventilated.
Primary Outcome
Samples for determination of cefiderocol concentrations in the epithelial lining fluid (ELF) were collected by bronchoalveolar lavage (BAL) procedure on the inflamed section of the lung (ie, a lobe where pneumonia was expected to be present based on chest radiologic imaging) after multiple doses of cefiderocol sufficient to approximate steady state concentrations in blood. The ELF sample for the determination of cefiderocol concentrations was collected at 3 hours after the start of administratio
Interventions
- DRUG Cefiderocol
- DRUG Standard of Care Antibiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-02-20 |
| Est. Completion | 2019-10-15 |
| Phase | Phase 1 |
Why NCT03862040 stopped before completion
NCT03862040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Cefiderocol is the first listed.
NCT03862040 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03862040 about?
NCT03862040 is a clinical study titled "Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia". The primary purpose of the study is to determine the degree of penetration of cefiderocol into infected lung tissue in hospitalized adults with bacterial pneumonia who are being mechanically ventilated.
What is the current status of trial NCT03862040?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-02-20. Estimated completion is 2019-10-15.
What interventions are being tested in trial NCT03862040?
The interventions under investigation include: Cefiderocol (DRUG), Standard of Care Antibiotic (DRUG).
Who is sponsoring clinical trial NCT03862040?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03862040's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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