Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

Phase 1TerminatedNCT00771719

Basilea Pharmaceutica1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ventilator Associated Pneumonia

Interventions

CeftobiproleDRUG

Ceftobiprole, 1 G q8h as 4 hour infusions for 2 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

Time frame: 2 days

Secondary Outcomes

Safety will be evaluated throughout the study.

Time frame: Study Duration

Data from ClinicalTrials.gov

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