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ISRCTN
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ISRCTN07092892
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ClinicalTrials.gov identifier
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Public title
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A double blind study of dexamethasone for the treatment of H5N1 Avian Influenza
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Scientific title
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Acronym
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DL Study
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Serial number at source
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061330
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Study hypothesis
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We have started to see new cases of H5N1 infection. Five new cases confirmed in the last week all from different provinces of southern Viet Nam suggesting widespread (and therefore difficult to control) distribution of the virus. We suspect that this epidemic will prove more extensive than 2004. There is more than 80% mortality in the confirmed cases and most severe cases have been in children and teenagers. All patients are managed in a dedicated ward with barrier nursing and medical care. All patients are treated with oseltamivir for five days. Some patients have been given steroids some have not. There is no evidence on which to guide treatment, drugs, doses or duration. We have documented massive cytokine release in the patients from 2004. Our TaqMan real time Polymerase Chain Reaction (PCR) results are available within 24 hours of a sample being taken.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Viet Nam
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Disease/condition/study domain
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Avian Influenza
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Participants - inclusion criteria
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1. Patients with confirmed TaqMan Influenza A positive, or H5N1 PCR
2. Patients with history of clear close exposure to sick poultry, Chest X-Ray changes consistent with H5N1, low white count and strong clinical suspicion of H5N1 infection
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Participants - exclusion criteria
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No consent
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Anticipated start date
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01/01/2005
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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4 - recruitment terminated as not enough patients
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Interventions
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Dexamethasone
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Primary outcome measure(s)
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Mortality
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Secondary outcome measure(s)
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1. Duration of ventilation
2. Duration of supplemental oxygen
3. Duration of hospitalisation
4. Viral load in clinical specimens
5. Cytokine levels
6. Adverse effects
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Sources of funding
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The Wellcome Trust (UK) (grant ref: 061330)
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Trial website
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Publications
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Contact name
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Dr
Jeremy
Farrar
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Address
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Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
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City/town
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Ho Chi Minh City
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Zip/Postcode
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5
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Country
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Viet Nam
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Tel
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+84 8 836 2225
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Fax
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+84 8 923 8904
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Email
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jeremyjf@hcm.vnn.vn
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Sponsor
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University of Oxford (UK)
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Address
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University Offices
Wellington Square
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City/town
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Oxford
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Zip/Postcode
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OX1 2JD
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Country
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United Kingdom
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Tel
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+44 (0)1865 270143
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Fax
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+44 (0)1865 280467
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Email
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research.services@admin.ox.ac.uk
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Sponsor website:
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http://www.ox.ac.uk
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Date applied
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22/07/2005
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Last edited
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13/12/2007
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Date ISRCTN assigned
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22/07/2005
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