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

This study has been terminated.
(stopped for futility)
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille Identifier:
First received: January 26, 2010
Last updated: October 29, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Pneumonia Drug: SIMVASTATIN Drug: PLACEBO Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia

Resource links provided by NLM:

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • The Primary efficacy measure is hospital mortality to day 28. [ Time Frame: 28 days after randomization ]

Enrollment: 300
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: PLACEBO
Half of the patients will be randomized to the placebo
Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU
Active Comparator: Simvastatin
Half of the subjects will receive the active drug, Simvastatin.
Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01057758

Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Principal Investigator: LAURENT PAPAZIAN Assistance Publique Hopitaux De Marseille
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT01057758     History of Changes
Other Study ID Numbers: 2008-002019-42
2008 13 ( Other Identifier: 2008 13 )
Study First Received: January 26, 2010
Last Updated: October 29, 2013

Keywords provided by Assistance Publique Hopitaux De Marseille:
Suspicion of ventilator-associated pneumonia

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on August 23, 2017