Trials / Terminated
TerminatedNCT03862040
Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
An Open-label, Multicenter, Single-arm, Phase 1 Study to Assess the Intrapulmonary Concentrations of Cefiderocol at Steady State in Hospitalized Subjects With Known or Suspected Bacterial Pneumonia on Treatment With Standard of Care Antibiotics and Requiring Mechanical Ventilation
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cefiderocol | Administered intravenously, at a dosage determined based on renal function. |
| DRUG | Standard of Care Antibiotic | Standard of care antibiotic treatment for pneumonia |
Timeline
- Start date
- 2019-02-20
- Primary completion
- 2019-10-08
- Completion
- 2019-10-15
- First posted
- 2019-03-05
- Last updated
- 2020-11-05
- Results posted
- 2020-11-05
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03862040. Inclusion in this directory is not an endorsement.