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

Primary Purpose

Pneumonia, Viral, Influenza in Humans

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

hydrocortisone

isotonic saline

About this trial

This is an interventional treatment trial for Pneumonia, Viral focused on measuring Acute lung injury, Acute respiratory distress syndrome, corticosteroids, inflammation

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Raymond Poincaré hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Corticosteroids

Control

Arm Description

Hydrocortisone

isotonic saline

Outcomes

Primary Outcome Measures

in hospital all cause morality

Secondary Outcome Measures

28 day mortality

90 day all cause mortality

6 month all cause mortality

mechanical ventilation free days

intensive care unit free days

proportion of patients with secondary infections

proportion of patients who require ECMO

respiratory function and health status

Full Information

NCT ID

NCT01014364

First Posted

November 16, 2009

Last Updated

December 17, 2014

Sponsor

University of Versailles

Collaborators

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT01014364

Brief Title

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

Acronym

CORTIFLU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Why Stopped

the H1N1 pandemic is now over, and fewer cases than expected were observed

Study Start Date

March 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Versailles

Collaborators

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Viral, Influenza in Humans

Keywords

Acute lung injury, Acute respiratory distress syndrome, corticosteroids, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Corticosteroids

Arm Type

Experimental

Arm Description

Hydrocortisone

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

isotonic saline

Intervention Type

Drug

Intervention Name(s)

hydrocortisone

Other Intervention Name(s)

hydrocortisone acetate

Intervention Description

50mg intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week

Intervention Type

Drug

Intervention Name(s)

isotonic saline

Other Intervention Name(s)

normal saline

Intervention Description

intravenous bolus every 6 hours for one week, then every 12 hours for one week and then every 24 hours for one week

Primary Outcome Measure Information:

Title

in hospital all cause morality

Time Frame

hospital discharge up to 90 days

Secondary Outcome Measure Information:

Title

28 day mortality

Time Frame

28 day

Title

90 day all cause mortality

Time Frame

90 day

Title

6 month all cause mortality

Time Frame

180 days

Title

mechanical ventilation free days

Time Frame

hospital discharge up to 90 days

Title

intensive care unit free days

Time Frame

hospital discharge up to 90 days

Title

proportion of patients with secondary infections

Time Frame

hospital discharge up to 90 days

Title

proportion of patients who require ECMO

Time Frame

hospital discharge up to 90 days

Title

respiratory function and health status

Time Frame

180 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: