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

NCT01014364 | Terminated Phase 3 DMC

• 1 other identifier: PCR09006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Viral; Influenza in Humans

Keywords

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

Outcome Measures

Primary Outcomes (1)

• in hospital all cause morality

  hospital discharge up to 90 days

Secondary Outcomes (8)

• 28 day mortality

  28 day

• 90 day all cause mortality

  90 day

• 6 month all cause mortality

  180 days

• mechanical ventilation free days

  hospital discharge up to 90 days

• intensive care unit free days

  hospital discharge up to 90 days

Study Arms (2)

Corticosteroids

EXPERIMENTAL

Hydrocortisone

Drug: hydrocortisone

Control

PLACEBO COMPARATOR

isotonic saline

Drug: isotonic saline

Interventions

hydrocortisone DRUG

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

Also known as: hydrocortisone acetate

Corticosteroids

isotonic saline DRUG

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

Also known as: normal saline

Control

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Versailles: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Raymond Poincaré hospital

Garches, 92380, France

Location

Related 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):29-39. doi: 10.1007/s00134-011-2409-8. Epub 2011 Nov 26.

  PMID: 22120766 RESULT

MeSH Terms

Conditions

Pneumonia, Viral; Influenza, Human; Acute Lung Injury; Respiratory Distress Syndrome; Inflammation

Interventions

Hydrocortisone; hydrocortisone acetate; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Lung Injury; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Djillali Annane, MD,PhD

  AP--HP and University of Versailles SQY

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the health Science Centre

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: March 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

FR (1)