Double blind placebo controlled trial of steroids in Bacterial Meningitis

ISRCTN	ISRCTN42986828
DOI	https://doi.org/10.1186/ISRCTN42986828
Protocol serial number	061330
Sponsor	University of Oxford (UK)
Funder	The Wellcome Trust (UK) (grant ref: 061330)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Jeremy Farrar
Scientific

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam

Phone	+84 8 8362225
Email	jfarrar@oucru.org

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Double blind placebo controlled trial of steroids in Bacterial Meningitis
Study acronym	BM Study
Study objectives	To investigate the effects of dexamethazone on the course and outcome of Bacterial Meningitis (BM) in adults in Viet Nam.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bacterial meningitis
Intervention	Double blind randomised controlled trial. The intervention will be dexamethasone.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dexamethazone
Primary outcome measure(s)	Mortality
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	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
Key exclusion criteria	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
Date of first enrolment	01/11/1996
Date of final enrolment	01/01/2000

Hospital for Tropical Diseases

Ho Chi Minh City
5
Viet Nam

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/10/2004		Yes	No
Results article		13/12/2007		Yes	No

28/10/2022: Internal review.