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

NCT01014364 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-12-18

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • University of Versailles

    lead OTHER

Principal Investigators

  • Djillali Annane, MD,PhD · AP--HP and University of Versailles SQY

  • Christian Brun Buisson, MD · AP-HP and Paris XII University

  • Charles Mayaud · AP-HP and University of Paris VII

  • Bernard Régnier · AP-HP and Paris VII University

  • Christian Perronne · AP-HP and University of Versailles SQY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014364 on ClinicalTrials.gov