Condition category
Infections and Infestations
Date applied
16/08/2005
Date assigned
07/09/2005
Last edited
18/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

College of Medicine Research Committee (Malawi)

Sponsor details

Private Bag 360
Chichiri
Blantyre
BT3
Malawi

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=18077809

Publication citations

  1. 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.

Additional files

Editorial Notes