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

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.

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

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)