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

Phase 3

Terminated

• Conditions: Pneumonia
• Interventions: Drug: PLACEBO; Drug: SIMVASTATIN

• Registration Number: NCT01057758
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed 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 Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-01-26
• Study First Posted: 2010-01-27
• Primary Completion: 2013-01
• Status Verified: 2013-04
• Study Completion: 2013-06
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PLACEBO	PLACEBO	Half of the patients will be randomized to the placebo
Simvastatin	SIMVASTATIN	Half of the subjects will receive the active drug, Simvastatin.

Primary Outcome Measures

Name	Time	Method
The Primary efficacy measure is hospital mortality to day 28.	28 days after randomization

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France