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
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia||Drug: SIMVASTATIN Drug: PLACEBO||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- The Primary efficacy measure is hospital mortality to day 28. [ Time Frame: 28 days after randomization ]
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
|Assistance Publique Hopitaux de Marseille|
|Principal Investigator:||LAURENT PAPAZIAN||Assistance Publique Hopitaux De Marseille|