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

Primary Purpose

Pneumonia

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

SIMVASTATIN

PLACEBO

About this trial

This is an interventional treatment trial for Pneumonia focused on measuring Suspicion of ventilator-associated pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

PLACEBO

Simvastatin

Arm Description

Half of the patients will be randomized to the placebo

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

Outcomes

Primary Outcome Measures

The Primary efficacy measure is hospital mortality to day 28.

Secondary Outcome Measures

Full Information

NCT ID

NCT01057758

First Posted

January 26, 2010

Last Updated

October 29, 2013

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT01057758

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Why Stopped

stopped for futility

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia

Keywords

Suspicion of ventilator-associated pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

300 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLACEBO

Arm Type

Placebo Comparator

Arm Description

Half of the patients will be randomized to the placebo

Arm Title

Simvastatin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

SIMVASTATIN

Intervention Description

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

Intervention Name(s)

PLACEBO

Intervention Description

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

Primary Outcome Measure Information:

Title

The Primary efficacy measure is hospital mortality to day 28.

Time Frame

28 days after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LAURENT PAPAZIAN

Organizational Affiliation

Assistance Publique Hopitaux De Marseille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assistance Publique Hopitaux de Marseille

City

Marseille

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

24108510

Citation

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.

Results Reference

derived

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

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