Dexamethasone adjuvant therapy and intramuscular ceftriaxone in bacterial meningitis amongst adults in an area of high human immunodeficiency virus (HIV) prevalence in Blantyre, Malawi

ISRCTN	ISRCTN31371499
DOI	https://doi.org/10.1186/ISRCTN31371499
Protocol serial number	P.98/99/30R
Sponsor	College of Medicine Research Committee (Malawi)
Funder	Meningitis Research Foundation (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Matthew Scarborough
Scientific

27 Oatlands Rd
Oxford
OX2 0EU
United Kingdom

Email	mattscar@talktalk.net

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SAM Trial (Steroids in Adult Meningitis)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Dexamethasone, ceftriaxione
Primary outcome measure(s)	Mortality at 40 days
Key secondary outcome measure(s)	1. Death or disability at 40 days 2. Clinically apparent hearing loss at 40 days 3. Death at six months
Completion date	31/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	420
Key inclusion criteria	All adults admitted to the Queen Elizabeth Central Hospital, Blantyre with a preliminary diagnosis of bacterial meningitis.
Key exclusion criteria	1. Age less than 16 years 2. Steroids received within the 24 hours preceeding admission
Date of first enrolment	15/05/2002
Date of final enrolment	31/01/2005

27 Oatlands Rd

Oxford
OX2 0EU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	13/12/2007		Yes	No