Trials / Terminated
TerminatedNCT00771719
Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
Open-Label Exploratory, Multiple-Dose Study of Ceftobiprole to Evaluate the Pharmacokinetics and Broncho-Alveolar Penetration in Adults With Ventilator-Associated Pneumonia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Basilea Pharmaceutica · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to measure the levels of ceftobiprole in the blood, urine and tissues of the lungs during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.
Detailed description
Patients will receive a intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of Ceftobiprole in the blood. Bronchoalveolar lavage (BAL) samples will be collected to determine the concentration of ceftobiprole in the BAL fluid. The penetration of the drug into the lung will be calculated. Four 1000mg administered every 8 hours
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ceftobiprole | Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2009-11-01
- Completion
- 2009-11-01
- First posted
- 2008-10-13
- Last updated
- 2012-07-30
Source: ClinicalTrials.gov record NCT00771719. Inclusion in this directory is not an endorsement.