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

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ClinicalTrials.gov Identifier: NCT01014364
Recruitment Status : Terminated (the H1N1 pandemic is now over, and fewer cases than expected were observed)
First Posted : November 17, 2009
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles

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
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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