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

Tracking Information
First Submitted Date ICMJE	November 16, 2009
First Posted Date ICMJE	November 17, 2009
Last Update Posted Date	December 18, 2014
Study Start Date ICMJE	March 2010
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 17, 2014)	in hospital all cause morality [ Time Frame: hospital discharge up to 90 days ]
Original Primary Outcome Measures ICMJE; (submitted: November 16, 2009)	in hospital all cause morality [ Time Frame: hospital discharge ]
Change History	Complete list of historical versions of study NCT01014364 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 17, 2014)	28 day mortality [ Time Frame: 28 day ]; 90 day all cause mortality [ Time Frame: 90 day ]; 6 month all cause mortality [ Time Frame: 180 days ]; mechanical ventilation free days [ Time Frame: hospital discharge up to 90 days ]; intensive care unit free days [ Time Frame: hospital discharge up to 90 days ]; proportion of patients with secondary infections [ Time Frame: hospital discharge up to 90 days ]; proportion of patients who require ECMO [ Time Frame: hospital discharge up to 90 days ]; respiratory function and health status [ Time Frame: 180 days ]
Original Secondary Outcome Measures ICMJE; (submitted: November 16, 2009)	28 day mortality [ Time Frame: 28 day ]; 90 day all cause mortality [ Time Frame: 90 day ]; 6 month all cause mortality [ Time Frame: 180 days ]; mechanical ventilation free days [ Time Frame: hospital discharge ]; intensive care unit free days [ Time Frame: hospital discharge ]; proportion of patients with secondary infections [ Time Frame: hospital discharge ]; proportion of patients who require ECMO [ Time Frame: hospital discharge ]; respiratory function and health status [ Time Frame: 180 days ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
Official Title ICMJE	Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Pneumonia, Viral; Influenza in Humans
Intervention ICMJE	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 Other Name: hydrocortisone acetate; 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 Other Name: normal saline
Study Arms	Experimental: Corticosteroids Hydrocortisone Intervention: Drug: hydrocortisone; Placebo Comparator: Control isotonic saline Intervention: Drug: isotonic saline
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Actual Enrollment ICMJE; (submitted: December 17, 2014)	40
Original Estimated Enrollment ICMJE; (submitted: November 16, 2009)	448
Actual Study Completion Date	December 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	15 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	France
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01014364
Other Study ID Numbers ICMJE	PCR09006
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Djillali Annane, University of Versailles
Study Sponsor ICMJE	University of Versailles
Collaborators ICMJE	Assistance Publique - Hôpitaux de Paris
Investigators ICMJE	Study Chair: Djillali Annane, MD,PhD AP--HP and University of Versailles SQY Principal Investigator: Christian Brun Buisson, MD AP-HP and Paris XII University Principal Investigator: Charles Mayaud AP-HP and University of Paris VII Principal Investigator: Bernard Régnier AP-HP and Paris VII University Principal Investigator: Christian Perronne AP-HP and University of Versailles SQY
PRS Account	University of Versailles
Verification Date	December 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP