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

This study has been terminated.
(stopped for futility)
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01057758
First received: January 26, 2010
Last updated: October 29, 2013
Last verified: April 2013

January 26, 2010
October 29, 2013
September 2009
January 2013   (final data collection date for primary outcome measure)
The Primary efficacy measure is hospital mortality to day 28. [ Time Frame: 28 days after randomization ] [ Designated as safety issue: No ]
The Primary efficacy measure is hospital mortality to day 28. [ Time Frame: 28 days after randomization ]
Complete list of historical versions of study NCT01057758 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
STATIN-VAP STATIN-VAP - STATINs and Ventilator-Associated Pneumonia
Effect of the Association of a Statin to Antibiotics on the Prognosis of Patients Presenting With a Suspicion of Ventilator-associated Pneumonia

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pneumonia
  • 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.
  • Drug: PLACEBO
    Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU
  • Placebo Comparator: PLACEBO
    Half of the patients will be randomized to the placebo
    Intervention: Drug: PLACEBO
  • Active Comparator: Simvastatin
    Half of the subjects will receive the active drug, Simvastatin.
    Intervention: Drug: SIMVASTATIN
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01057758
2008-002019-42, 2008 13
Yes
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Principal Investigator: LAURENT PAPAZIAN Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP