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