Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu

• Status: Terminated
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Versailles
• Collaborator: Assistance Publique - Hôpitaux de Paris
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate

Criteria

Inclusion Criteria:

• age above 15 years old

• admitted to intensive care unit

• proven or strong suspicion of H1N1 Influenza infection

• diffuse pneumonia (for less than 96 hours)

• need for non invasive or invasive mechanical ventilation

Exclusion Criteria:

• pregnancy

• an age of 15 or less

• rapidly fatal underlying disease with a life expectancy of one month or less

• more than 3 organ dysfunction upon admission

• previous treatment with corticosteroids (ie prednisone 30 mg per day or more, or equivalent, for at least one month)

• formal indication for corticosteroids (eg Addison disease, status asthmaticus)

• already on corticosteroids for 2 days or more in the management of the current episode

• acute lung injury not related to viral pneumonia

• presence of H1N1 related acute myocarditis or encephalitis

• receiving antiviral treatment for more than 5 days