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

This study has been terminated.

(the H1N1 pandemic is now over, and fewer cases than expected were observed)

Sponsor:

Collaborator:

Assistance Publique - Hôpitaux de Paris

Information provided by (Responsible Party):

Djillali Annane, University of Versailles

ClinicalTrials.gov Identifier:

NCT01014364

First received: November 16, 2009

Last updated: December 17, 2014

Last verified: December 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

November 16, 2009

Last Updated Date

December 17, 2014

Start Date ^ICMJE

March 2010

Primary Completion Date

June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

in hospital all cause morality [ Time Frame: hospital discharge up to 90 days ]

Original Primary Outcome Measures ^ICMJE

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

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

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

Enrollment ^ICMJE

Completion Date

December 2011

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

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

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