- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01014364
Low Doses Corticosteroids as Adjuvant Therapy for the Treatment of Severe H1N1 Flu (CORTIFLU)
December 17, 2014 updated by: Djillali Annane, University of Versailles
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Garches, France, 92380
- Raymond Poincaré Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Corticosteroids
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 Names:
|
Placebo Comparator: Control
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
in hospital all cause morality
Time Frame: hospital discharge up to 90 days
|
hospital discharge up to 90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
28 day mortality
Time Frame: 28 day
|
28 day
|
90 day all cause mortality
Time Frame: 90 day
|
90 day
|
6 month all cause mortality
Time Frame: 180 days
|
180 days
|
mechanical ventilation free days
Time Frame: hospital discharge up to 90 days
|
hospital discharge up to 90 days
|
intensive care unit free days
Time Frame: hospital discharge up to 90 days
|
hospital discharge up to 90 days
|
proportion of patients with secondary infections
Time Frame: hospital discharge up to 90 days
|
hospital discharge up to 90 days
|
proportion of patients who require ECMO
Time Frame: hospital discharge up to 90 days
|
hospital discharge up to 90 days
|
respiratory function and health status
Time Frame: 180 days
|
180 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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 and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 16, 2009
First Submitted That Met QC Criteria
November 16, 2009
First Posted (Estimate)
November 17, 2009
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Orthomyxoviridae Infections
- Pneumonia
- Influenza, Human
- Pneumonia, Viral
- Anti-Inflammatory Agents
- Hydrocortisone
- Hydrocortisone 17-butyrate 21-propionate
- Hydrocortisone acetate
- Hydrocortisone hemisuccinate
Other Study ID Numbers
- PCR09006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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