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

This study has suspended participant recruitment.
(the H1N1 pandemic is now over, and fewer cases than expected were observed)
Sponsor:
Collaborator:
Assistance Publique - Hôpitaux de Paris
Information provided by:
University of Versailles
ClinicalTrials.gov Identifier:
NCT01014364
First received: November 16, 2009
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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 A Virus, H1N1 Subtype
Drug: hydrocortisone
Drug: isotonic saline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 28 day mortality [ Time Frame: 28 day ] [ Designated as safety issue: Yes ]
  • 90 day all cause mortality [ Time Frame: 90 day ] [ Designated as safety issue: Yes ]
  • 6 month all cause mortality [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • mechanical ventilation free days [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
  • intensive care unit free days [ Time Frame: hospital discharge ] [ Designated as safety issue: No ]
  • proportion of patients with secondary infections [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • proportion of patients who require ECMO [ Time Frame: hospital discharge ] [ Designated as safety issue: Yes ]
  • respiratory function and health status [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 448
Study Start Date: March 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticosteroids
Hydrocortisone
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
Placebo Comparator: Control 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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01014364

Locations
France
Raymond Poincaré hospital
Garches, France, 92380
Sponsors and Collaborators
University of Versailles
Assistance Publique - Hôpitaux de Paris
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
  More Information

No publications provided by University of Versailles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cécile Kedzia, Assistance Publique Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01014364     History of Changes
Other Study ID Numbers: PCR09006
Study First Received: November 16, 2009
Last Updated: July 21, 2010
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Viral
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone-17-butyrate
Anti-Inflammatory Agents
Dermatologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014