Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has suspended participant recruitment.
(the H1N1 pandemic is now over, and fewer cases than expected were observed)
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT01014364
First received: November 16, 2009
Last updated: July 21, 2010
Last verified: July 2010

November 16, 2009
July 21, 2010
March 2010
June 2011   (final data collection date for primary outcome measure)
in hospital all cause morality [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014364 on ClinicalTrials.gov Archive Site
  • 28 day mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • 90 day all cause mortality [ Time Frame: 90 day ] [ Designated as safety issue: Yes ]
  • 6 month all cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • mechanical ventilation free days [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
  • intensive care unit free days [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
  • proportion of patients with secondary infections [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • proportion of patients who require ECMO [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • respiratory function and health status [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu
Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pneumonia, Viral
  • Influenza A Virus, H1N1 Subtype
  • 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
  • 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
  • Experimental: Corticosteroids
    Hydrocortisone
    Intervention: Drug: hydrocortisone
  • Placebo Comparator: Control
    Intervention: Drug: isotonic saline
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.
 
Suspended
448
December 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01014364
PCR09006
Yes
Cécile Kedzia, Assistance Publique Hôpitaux de Paris
University of Versailles
Assistance Publique - Hôpitaux de Paris
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
University of Versailles
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP