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Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia

2014-08-27 03:26:58 | BioPortfolio

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.

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Ventilator Associated Pneumonia

Intervention

Ceftobiprole

Status

Terminated

Source

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:26:58-0400

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Medical and Biotech [MESH] Definitions

Serious INFLAMMATION of the LUNG in patients who required the use of PULMONARY VENTILATOR. It is usually caused by cross bacterial infections in hospitals (NOSOCOMIAL INFECTIONS).

Lung damage that is caused by the adverse effects of PULMONARY VENTILATOR usage. The high frequency and tidal volumes produced by a mechanical ventilator can cause alveolar disruption and PULMONARY EDEMA.

Pneumonia due to aspiration or inhalation of various oily or fatty substances.

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

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