Clinical Trial: Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
Brief Summary: The H1N1 flu pandemic is one of the major infectious threat of the past half century. it is rapidly progressing worldwide and a substantial number of patients get severe H1N1 related pneumonia that requires mechanical ventilation and admission to the intensive care unit. The acute respiratory distress syndrome is associated with a substantial mortality and morbidity partly as a consequence of uncontrolled lung and systemic inflammation. many physicians are trying to counteract this pro-inflammatory storm by the use of corticosteroids albeit these drugs may cause super infection or metabolic disorders. Thus, there is a need for a randomized double blind, placebo controlled trial to define the benefit to risk ratio of corticosteroids in this patient.
Detailed Summary:
Sponsor: University of Versailles
Current Primary Outcome: in hospital all cause morality [ Time Frame: hospital discharge up to 90 days ]
Original Primary Outcome: in hospital all cause morality [ Time Frame: hospital discharge ]
Current Secondary Outcome:
- 28 day mortality [ Time Frame: 28 day ]
- 90 day all cause mortality [ Time Frame: 90 day ]
- 6 month all cause mortality [ Time Frame: 180 days ]
- mechanical ventilation free days [ Time Frame: hospital discharge up to 90 days ]
- intensive care unit free days [ Time Frame: hospital discharge up to 90 days ]
- proportion of patients with secondary infections [ Time Frame: hospital discharge up to 90 days ]
- proportion of patients who require ECMO [ Time Frame: hospital discharge up to 90 days ]
- respiratory function and health status [ Time Frame: 180 days ]
Original Secondary Outcome:
- 28 day mortality [ Time Frame: 28 day ]
- 90 day all cause mortality [ Time Frame: 90 day ]
- 6 month all cause mortality [ Time Frame: 180 days ]
- mechanical ventilation free days [ Time Frame: hospital discharge ]
- intensive care unit free days [ Time Frame: hospital discharge ]
- proportion of patients with secondary infections [ Time Frame: hospital discharge ]
- proportion of patients who require ECMO [ Time Frame: hospital discharge ]
- respiratory function and health status [ Time Frame: 180 days ]
Information By: University of Versailles
Dates:
Date Received: November 16, 2009
Date Started: March 2010
Date Completion:
Last Updated: December 17, 2014
Last Verified: December 2014