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

Pneumonia Clinical Trial

Official title:

Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01057758
• Other study ID #: 2008-002019-42
• Secondary ID: 2008 13
• Status: Terminated
• Phase: Phase 3
• First received: January 26, 2010
• Last updated: October 29, 2013
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

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

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary efficacy measure is hospital mortality to day 28.		28 days after randomization	No