STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia
This study is ongoing, but not recruiting participants.
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01057758
First received: January 26, 2010
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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 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 |
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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 992 |
| Study Start Date: | September 2009 |
| Estimated 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
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT01057758 History of Changes |
| Other Study ID Numbers: | 2008-002019-42, 2008 13 |
| Study First Received: | January 26, 2010 |
| Last Updated: | April 29, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013