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

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ClinicalTrials.gov Identifier: NCT01057758
Recruitment Status : Terminated (stopped for futility)
First Posted : January 27, 2010
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pneumonia Drug: SIMVASTATIN Drug: PLACEBO Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: PLACEBO
Half of the patients will be randomized to the placebo
Drug: 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.
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.



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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057758


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01057758     History of Changes
Other Study ID Numbers: 2008-002019-42
2008 13 ( Other Identifier: 2008 13 )
First Posted: January 27, 2010    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection
Ventilator-Induced Lung Injury
Lung Injury
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors