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ISRCTN
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ISRCTN31371499
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ClinicalTrials.gov identifier
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Public title
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Dexamethasone adjuvant therapy and intramuscular ceftriaxone in bacterial meningitis amongst adults in an area of high human immunodeficiency virus (HIV) prevalence in Blantyre, Malawi
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Scientific title
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Acronym
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SAM Trial (Steroids in Adult Meningitis)
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Serial number at source
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P.98/99/30R
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Study hypothesis
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1. Dexamethasone, by limiting the host inflammatory response in bacterial meningitis, will reduce mortality and morbidity
2. Ceftriaxone is as effective given intramuscularly (IM) as it is when given intravenously (IV) and may therefore be used in rural areas where IV therapy is unavailable
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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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Malawi
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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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All adults admitted to the Queen Elizabeth Central Hospital, Blantyre with a preliminary diagnosis of bacterial meningitis.
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Participants - exclusion criteria
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1. Age less than 16 years
2. Steroids received within the 24 hours preceeding admission
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Anticipated start date
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15/05/2002
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Anticipated end date
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31/01/2005
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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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420
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Interventions
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Dexamethasone 16 mg twice daily for 4 days versus placebo.
Ceftriaxone 2 mg twice daily for ten days given either IV or IM.
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Primary outcome measure(s)
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Mortality at 40 days
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Secondary outcome measure(s)
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1. Death or disability at 40 days
2. Clinically apparent hearing loss at 40 days
3. Death at six months
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Sources of funding
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Meningitis Research Foundation (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=18077809
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Contact name
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Dr
Matthew
Scarborough
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Address
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27 Oatlands Rd
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City/town
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Oxford
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Zip/Postcode
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OX2 0EU
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Country
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United Kingdom
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Email
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mattscar@talktalk.net
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Sponsor
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College of Medicine Research Committee (Malawi)
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Address
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Private Bag 360
Chichiri
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City/town
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Blantyre
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Zip/Postcode
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BT3
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Country
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Malawi
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Date applied
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16/08/2005
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Last edited
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18/12/2007
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Date ISRCTN assigned
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07/09/2005
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