Contact information
Type
Scientific
Primary contact
Dr Matthew Scarborough
ORCID ID
Contact details
27 Oatlands Rd
Oxford
OX2 0EU
United Kingdom
mattscar@talktalk.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P.98/99/30R
Study information
Scientific title
Acronym
SAM Trial (Steroids in Adult Meningitis)
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Bacterial Meningitis
Intervention
Dexamethasone 16 mg twice daily for 4 days versus placebo.
Ceftriaxone 2 mg twice daily for ten days given either IV or IM.
Intervention type
Drug
Phase
Not Specified
Drug names
Dexamethasone, ceftriaxione
Primary outcome measure
Mortality at 40 days
Secondary outcome measures
1. Death or disability at 40 days
2. Clinically apparent hearing loss at 40 days
3. Death at six months
Overall trial start date
15/05/2002
Overall trial end date
31/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adults admitted to the Queen Elizabeth Central Hospital, Blantyre with a preliminary diagnosis of bacterial meningitis.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
420
Participant exclusion criteria
1. Age less than 16 years
2. Steroids received within the 24 hours preceeding admission
Recruitment start date
15/05/2002
Recruitment end date
31/01/2005
Locations
Countries of recruitment
Malawi
Trial participating centre
27 Oatlands Rd
Oxford
OX2 0EU
United Kingdom
Funders
Funder type
Charity
Funder name
Meningitis Research Foundation (UK)
Alternative name(s)
MRF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=18077809
Publication citations
-
Results
Scarborough M, Gordon SB, Whitty CJ, French N, Njalale Y, Chitani A, Peto TE, Lalloo DG, Zijlstra EE, Corticosteroids for bacterial meningitis in adults in sub-Saharan Africa., N. Engl. J. Med., 2007, 357, 24, 2441-2450, doi: 10.1056/NEJMoa065711.