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

NCT ID: NCT01014364

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Pneumonia, Viral Influenza in Humans

Keywords

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Acute lung injury Acute respiratory distress syndrome corticosteroids inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Corticosteroids

Hydrocortisone

Group Type EXPERIMENTAL

hydrocortisone

Intervention Type DRUG

50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week

Control

isotonic saline

Group Type PLACEBO_COMPARATOR

isotonic saline

Intervention Type DRUG

intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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hydrocortisone acetate normal saline

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

University of Versailles

OTHER

Sponsor Role lead

Responsible Party

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Djillali Annane

Dean of the health Science Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Djillali Annane, MD,PhD

Role: STUDY_CHAIR

AP--HP and University of Versailles SQY

Christian Brun Buisson, MD

Role: PRINCIPAL_INVESTIGATOR

AP-HP and Paris XII University

Charles Mayaud

Role: PRINCIPAL_INVESTIGATOR

AP-HP and University of Paris VII

Bernard Régnier

Role: PRINCIPAL_INVESTIGATOR

AP-HP and Paris VII University

Christian Perronne

Role: PRINCIPAL_INVESTIGATOR

AP-HP and University of Versailles SQY

Locations

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Raymond Poincaré hospital

Garches, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 22120766 (View on PubMed)

Other Identifiers

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PCR09006

Identifier Type: -

Identifier Source: org_study_id