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

Phase 3TerminatedNCT01057758

Assistance Publique Hopitaux De Marseille300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

300

Conditions

Pneumonia

Interventions

SIMVASTATINDRUG

Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.

PLACEBODRUG

Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Duration of mechanical ventilation \> 48 h * First episode of suspicion of VAP with a Clinical Pulmonary Infection Score modified ≥ 5 * BAL, plugged telescopic catheter and/or tracheal aspirates quantitative cultures performed prior administration of antibiotics * Informed consent Exclusion Criteria: * Statin treatment received under mechanical ventilation * Age less than 18 years * Pregnancy * Unable to receive or unlikely to absorb enteral study drug * Patient, surrogate, or physician not committed to full support ). * Moribund patient with a SAPS II score \> 75 * Simvastatin specific exclusions Allergy or intolerance to statins Physician insistence for the use or avoidance of statins during the current hospitalization CK , ALT or AST \> 5 times the upper limit of normal Receiving cyclosporine, gemfibrozil, lopinavir, ritonavir itraconazole, kétoconazole, érythromycine, clarithromycine, télithromycine, néfazodone, verapamil, diltiazem * Severe chronic liver disease

Locations (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Outcomes

Primary Outcomes

The Primary efficacy measure is hospital mortality to day 28.

Time frame: 28 days after randomization

Data from ClinicalTrials.gov

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