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

Pneumonia, Viral Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza in Humans
• Influenza, Human
• Pneumonia
• Pneumonia, Viral

• NCT number: NCT01014364
• Study type: Interventional
• Source: University of Versailles
• Status: Terminated
• Phase: Phase 3
• Start date: March 2010
• Completion date: December 2011