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

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:
  • hydrocortisone acetate
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:
  • normal saline

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.

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

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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