Clinical trial NCT01014364: Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
Official title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia, Viral
Influenza in Humans
Keywords: Acute lung injury
Acute respiratory distress syndrome
corticosteroids
inflammation
Lead sponsor: University of Versailles
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2009-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: in hospital all cause morality
timeFrame: hospital discharge up to 90 days
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 day
measure: 90 day all cause mortality
timeFrame: 90 day
measure: 6 month all cause mortality
timeFrame: 180 days
measure: mechanical ventilation free days
timeFrame: hospital discharge up to 90 days
measure: intensive care unit free days
timeFrame: hospital discharge up to 90 days
measure: proportion of patients with secondary infections
timeFrame: hospital discharge up to 90 days
measure: proportion of patients who require ECMO
timeFrame: hospital discharge up to 90 days
measure: respiratory function and health status
timeFrame: 180 days
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré hospital
Study officials:
affiliation: AP--HP and University of Versailles SQY
name: Djillali Annane, MD,PhD
role: STUDY_CHAIR
affiliation: AP-HP and Paris XII University
name: Christian Brun Buisson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP and University of Paris VII
name: Charles Mayaud
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP and Paris VII University
name: Bernard Régnier
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP and University of Versailles SQY
name: Christian Perronne
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annane D, Antona M, Lehmann B, Kedzia C, Chevret S; CORTIFLU Investigators; CRICs; AZUREA; REVA/SRLF networks. Designing and conducting a randomized trial for pandemic critical illness: the 2009 H1N1 influenza pandemic. Intensive Care Med. 2012 Jan;38(1):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26.