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

University of Versailles

Status and phase: Terminated; Phase 3

Conditions: Influenza in Humans; Pneumonia, Viral

Treatments: Drug: hydrocortisone; Drug: isotonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01014364

PCR09006

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Corticosteroids

Experimental group

Description:

Hydrocortisone

Treatment:

Drug: hydrocortisone

Control

Placebo Comparator group

Description:

isotonic saline

Treatment:

Drug: isotonic saline