Study Stopped
stopped for futility
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
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2009
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 30, 2013
April 1, 2013
3.3 years
January 26, 2010
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Primary efficacy measure is hospital mortality to day 28.
28 days after randomization
Study Arms (2)
PLACEBO
PLACEBO COMPARATORHalf of the patients will be randomized to the placebo
Simvastatin
ACTIVE COMPARATORHalf of the subjects will receive the active drug, Simvastatin.
Interventions
Patients will receive 60 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study ICU.
Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study ICU
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Severe chronic liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, France
Related Publications (1)
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.
PMID: 24108510DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LAURENT PAPAZIAN
Assistance Publique Hopitaux De Marseille
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
January 27, 2010
Study Start
September 1, 2009
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
October 30, 2013
Record last verified: 2013-04