NCT01014364

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

Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Versailles · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Viral
• Influenza in Humans

Interventions

Type	Name	Description
DRUG	hydrocortisone	50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week
DRUG	isotonic saline	intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2011-12-01
• First posted: 2009-11-17
• Last updated: 2014-12-18

Locations

1 site across 1 country: France