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

NCT ID: NCT01057758

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-06-30

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.

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.

Conditions

Pneumonia

Keywords

Suspicion of ventilator-associated pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PLACEBO

Half of the patients will be randomized to the placebo

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DRUG

Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU

Simvastatin

Half of the subjects will receive the active drug, Simvastatin.

Group Type: ACTIVE_COMPARATOR

SIMVASTATIN

Intervention Type: DRUG

Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.

Interventions

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.

Intervention Type: DRUG

PLACEBO

Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LAURENT PAPAZIAN

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique Hopitaux De Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

References

Papazian L, Roch A, Charles PE, Penot-Ragon C, Perrin G, Roulier P, Goutorbe P, Lefrant JY, Wiramus S, Jung B, Perbet S, Hernu R, Nau A, Baldesi O, Allardet-Servent J, Baumstarck K, Jouve E, Moussa M, Hraiech S, Guervilly C, Forel JM; STATIN-VAP Study Group. Effect of statin therapy on mortality in patients with ventilator-associated pneumonia: a randomized clinical trial. JAMA. 2013 Oct 23;310(16):1692-700. doi: 10.1001/jama.2013.280031.

Reference Type: DERIVED

PMID: 24108510 (View on PubMed)

Other Identifiers

2008 13

Identifier Type: OTHER

Identifier Source: secondary_id

2008-002019-42

Identifier Type: -

Identifier Source: org_study_id