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
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Sponsor:
University of Versailles
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles
Tracking Information | ||||||||||||||||
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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 |
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 | ||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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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. |
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Recruitment Information | ||||||||||||||||
Recruitment Status ICMJE | Terminated | |||||||||||||||
Actual Enrollment ICMJE |
40 | |||||||||||||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |