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

Pneumonia, Viral Clinical Trial

— CORTIFLU  

Official title:

Phase III Study of Hydrocortisone in Patients With Severe H1N1 Related Pneumonia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01014364
• Other study ID #: PCR09006
• Status: Terminated
• Phase: Phase 3
• First received: November 16, 2009
• Last updated: December 17, 2014
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2014
• Source: University of Versailles
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza in Humans
• Influenza, Human
• Pneumonia
• Pneumonia, Viral

Intervention

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
• 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

Locations

Country	Name	City	State
France	Raymond Poincaré hospital	Garches

Sponsors (2)

Lead Sponsor	Collaborator
University of Versailles	Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in hospital all cause morality		hospital discharge up to 90 days	Yes
Secondary	28 day mortality		28 day	Yes
Secondary	90 day all cause mortality		90 day	Yes
Secondary	6 month all cause mortality		180 days	Yes
Secondary	mechanical ventilation free days		hospital discharge up to 90 days	No
Secondary	intensive care unit free days		hospital discharge up to 90 days	No
Secondary	proportion of patients with secondary infections		hospital discharge up to 90 days	Yes
Secondary	proportion of patients who require ECMO		hospital discharge up to 90 days	Yes
Secondary	respiratory function and health status		180 days	Yes