Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 2 of 10 for:    "Pneumonia, Viral"

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

This study has been terminated.
(the H1N1 pandemic is now over, and fewer cases than expected were observed)
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Djillali Annane, University of Versailles Identifier:
First received: November 16, 2009
Last updated: December 17, 2014
Last verified: December 2014
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.

Condition Intervention Phase
Pneumonia, Viral
Influenza in Humans
Drug: hydrocortisone
Drug: isotonic saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia

Resource links provided by NLM:

Further study details as provided by University of Versailles:

Primary Outcome Measures:
  • in hospital all cause morality [ Time Frame: hospital discharge up to 90 days ]

Secondary Outcome Measures:
  • 28 day mortality [ Time Frame: 28 day ]
  • 90 day all cause mortality [ Time Frame: 90 day ]
  • 6 month all cause mortality [ Time Frame: 180 days ]
  • mechanical ventilation free days [ Time Frame: hospital discharge up to 90 days ]
  • intensive care unit free days [ Time Frame: hospital discharge up to 90 days ]
  • proportion of patients with secondary infections [ Time Frame: hospital discharge up to 90 days ]
  • proportion of patients who require ECMO [ Time Frame: hospital discharge up to 90 days ]
  • respiratory function and health status [ Time Frame: 180 days ]

Enrollment: 40
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticosteroids
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
Other Name: hydrocortisone acetate
Placebo Comparator: Control
isotonic saline
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
Other Name: normal saline


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01014364

Raymond Poincaré hospital
Garches, France, 92380
Sponsors and Collaborators
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
  More Information

Responsible Party: Djillali Annane, Dean of the health Science Centre, University of Versailles Identifier: NCT01014364     History of Changes
Other Study ID Numbers: PCR09006
Study First Received: November 16, 2009
Last Updated: December 17, 2014

Keywords provided by University of Versailles:
Acute lung injury
Acute respiratory distress syndrome

Additional relevant MeSH terms:
Pneumonia, Viral
Influenza, Human
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone acetate
Anti-Inflammatory Agents processed this record on May 23, 2017