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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Terminated; Phase 3

Conditions: Pneumonia

Treatments: Drug: SIMVASTATIN; Drug: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT01057758

2008 13 (Other Identifier)

2008-002019-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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300 participants in 2 patient groups, including a placebo group

PLACEBO

Placebo Comparator group

Description:

Half of the patients will be randomized to the placebo

Treatment:

Drug: PLACEBO

Simvastatin

Active Comparator group

Description:

Half of the subjects will receive the active drug, Simvastatin.

Treatment:

Drug: SIMVASTATIN