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

Phase 3

Terminated

• Conditions: Pneumonia, Viral; Influenza in Humans
• Interventions: Drug: isotonic saline; Drug: hydrocortisone

• Registration Number: NCT01014364
• Lead Sponsor: University of Versailles

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 Description

Not available

Study Timeline

• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Study Start: 2010-03
• Primary Completion: 2011-06
• Study Completion: 2011-12
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	isotonic saline	isotonic saline
Corticosteroids	hydrocortisone	Hydrocortisone

Primary Outcome Measures

Name	Time	Method
in hospital all cause morality	hospital discharge up to 90 days

Secondary Outcome Measures

Name	Time	Method
6 month all cause mortality	180 days
intensive care unit free days	hospital discharge up to 90 days
proportion of patients with secondary infections	hospital discharge up to 90 days
mechanical ventilation free days	hospital discharge up to 90 days
proportion of patients who require ECMO	hospital discharge up to 90 days
90 day all cause mortality	90 day
28 day mortality	28 day
respiratory function and health status	180 days

Trial Locations

Locations (1)

Raymond Poincaré hospital; 🇫🇷 Garches, France