Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Basilea Pharmaceutica

Status and phase

Terminated

Phase 1

Conditions

Ventilator Associated Pneumonia

Treatments

Drug: Ceftobiprole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00771719

NOS-1002 (Other Identifier)

CR015304

Details and patient eligibility

About

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.

Full 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

Enrollment

1 patient

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)