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STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia

2014-08-27 03:16:20 | BioPortfolio

Summary

The objective is to assess the efficacy and safety of oral simvastatin in patients with a suspicion of ventilator-associated pneumonia (VAP). The hypothesis of this study is that simvastatin therapy will improve mortality in patients a suspicion of VAP.

Description

When a patient will present a suspicion of VAP (Clinical Pulmonary Infection Score modified ≥ 5), Simvastatin or placebo will be administered with antibiotics. Quantitative cultures will be performed for microbiological confirmation of VAP. Simvastatin or placebo will be administered through an enteral feeding tube or administered orally when patients are able to safely take oral medications. The type and placement of the enteral feeding tube (nasogastric, nasoenteric, PEG, orogastric, oroenteric, etc.) and the ability to safely take oral medications will be determined by the patient's primary team. Study drug will be blinded with an identical appearing placebo.

Sequential Organ Failure Assessment score (SOFA), and various blood factors will be measured during treatment.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Pneumonia

Intervention

SIMVASTATIN, PLACEBO

Location

Assistance Publique Hopitaux de Marseille
Marseille
France

Status

Recruiting

Source

Assistance Publique Hopitaux De Marseille

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:20-0400

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of ezetimibe and simvastatin that is used in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.

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

Pneumonia caused by infection with bacteria of the family RICKETTSIACEAE.

Severe complication of pneumonia characterized by liquefaction of lung tissue.

A species of the genus PNEUMOVIRUS causing pneumonia in mice.

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