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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles

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.

Condition or disease Intervention/treatment Phase
Pneumonia, Viral Influenza in Humans Drug: hydrocortisone Drug: isotonic saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Corticosteroids
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

Placebo Comparator: Control
isotonic saline
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

Primary Outcome Measures :
  1. in hospital all cause morality [ Time Frame: hospital discharge up to 90 days ]

Secondary Outcome Measures :
  1. 28 day mortality [ Time Frame: 28 day ]
  2. 90 day all cause mortality [ Time Frame: 90 day ]
  3. 6 month all cause mortality [ Time Frame: 180 days ]
  4. mechanical ventilation free days [ Time Frame: hospital discharge up to 90 days ]
  5. intensive care unit free days [ Time Frame: hospital discharge up to 90 days ]
  6. proportion of patients with secondary infections [ Time Frame: hospital discharge up to 90 days ]
  7. proportion of patients who require ECMO [ Time Frame: hospital discharge up to 90 days ]
  8. respiratory function and health status [ Time Frame: 180 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01014364

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Raymond Poincaré hospital
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
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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
Publications of Results:
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Responsible Party: Djillali Annane, Dean of the health Science Centre, University of Versailles Identifier: NCT01014364    
Other Study ID Numbers: PCR09006
First Posted: November 17, 2009    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Djillali Annane, University of Versailles:
Acute lung injury
Acute respiratory distress syndrome
Additional relevant MeSH terms:
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Pneumonia, Viral
Influenza, Human
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents