STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- The Primary efficacy measure is hospital mortality to day 28. [ Time Frame: 28 days after randomization ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||June 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
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.
|Assistance Publique Hopitaux de Marseille|
|Principal Investigator:||LAURENT PAPAZIAN||Assistance Publique Hopitaux De Marseille|