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ISRCTN
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ISRCTN42986828
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ClinicalTrials.gov identifier
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Public title
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Double blind placebo controlled trial of steroids in Bacterial Meningitis
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Scientific title
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Acronym
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BM Study
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Serial number at source
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061330
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Study hypothesis
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To investigate the effects of dexamethazone on the course and outcome of Bacterial Meningitis (BM) in adults in Viet Nam.
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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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Bacterial meningitis
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Participants - inclusion criteria
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1. The treating physician believes the diagnosis to be BM
2. History less than ten days (unless still Serebrospinal Fluid [CSF] evidence of bacteria)
3. CSF white cell count more than 50 with more than 50% neutrophils
4. CSF glucose less than 50% of blood glucose
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Participants - exclusion criteria
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1. Chest X-Ray (CXR) shows evidence of possible Tuberculosis (TB)
2. History is longer than ten days
3. History of hypersensitivity to beta-lactam antibiotics
4. Known severe liver or renal impairment
5. Patients in whom the physician believes corticosteroids are contraindicated e.g. uncontrolled diabetes, gastro-intestinal bleeding etc.
6. Pre-existing severe neurological disability
7. Pregnancy within the first trimester
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Anticipated start date
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01/11/1996
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Anticipated end date
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01/01/2000
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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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To be added
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Interventions
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Double blind randomised controlled trial. The intervention will be 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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No secondary outcome measures
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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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Results in:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=15496623
2. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=18077808
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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 8362225
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Fax
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+84 8 9238904
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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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18/12/2007
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Date ISRCTN assigned
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22/07/2005
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