Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia
- Registration Number
- NCT00771719
- Lead Sponsor
- Basilea Pharmaceutica
- Brief 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Inclusion Criteria
- Informed Consent
- Between 18 and 75 years of age inclusive
- VAP - 48 hours after onset of mechanical ventilation
- BMI 18 - 35 inclusive
- Albumin < 3.3 g/dL or clinical evidence of edema
- Negative Pregnancy test
- Expected survival of at least 7 days
Exclusion Criteria
- Renal impairment (CrCl < 80 mL/min)
- Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
- History of seizures
- Sustained shock, unresponsive to sympathomimetics
- Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, >15% total body burn or significant third degree burn)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ceftobiprole Ceftobiprole Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days
- Primary Outcome Measures
Name Time Method Pharmacokinetics (to measure the levels of ceftobiprole in the blood and urine and tissues of the lungs) during dosing and 24 hours after last dose infused 2 days
- Secondary Outcome Measures
Name Time Method Safety will be evaluated throughout the study. Study Duration