Condition category
Nervous System Diseases
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
11/03/2013
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 Jeremy Farrar

ORCID ID

Contact details

Hospital for Tropical Diseases
The Hospital for Tropical Diseases
Oxford University Clinical Research
190 Ben Ham Tu
Ho Chi Minh City
5
Viet Nam
+84 8 8362225
jfarrar@oucru.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

061330

Study information

Scientific title

Acronym

BM Study

Study hypothesis

To investigate the effects of dexamethazone on the course and outcome of Bacterial Meningitis (BM) in adults in Viet Nam.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Bacterial meningitis

Intervention

Double blind randomised controlled trial. The intervention will be dexamethasone.

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethazone

Primary outcome measures

Mortality

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/1996

Overall trial end date

01/01/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

To be added

Participant 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

Recruitment start date

01/11/1996

Recruitment end date

01/01/2000

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

http://www.ox.ac.uk

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 061330)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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:
1. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=15496623
2. http://www.ncbi.nlm.nih.gov/sites/entrez?db=pubmed&cmd=Retrieve&list_uids=18077808

Publication citations

  1. Thwaites GE, Nguyen DB, Nguyen HD, Hoang TQ, Do TT, Nguyen TC, Nguyen QH, Nguyen TT, Nguyen NH, Nguyen TN, Nguyen NL, Nguyen HD, Vu NT, Cao HH, Tran TH, Pham PM, Nguyen TD, Stepniewska K, White NJ, Tran TH, Farrar JJ, Dexamethasone for the treatment of tuberculous meningitis in adolescents and adults., N. Engl. J. Med., 2004, 351, 17, 1741-1751, doi: 10.1056/NEJMoa040573.

  2. Nguyen TH, Tran TH, Thwaites G, Ly VC, Dinh XS, Ho Dang TN, Dang QT, Nguyen DP, Nguyen HP, To SD, Nguyen vV, Nguyen MD, Campbell J, Schultsz C, Parry C, Torok ME, White N, Nguyen TC, Tran TH, Stepniewska K, Farrar JJ, Dexamethasone in Vietnamese adolescents and adults with bacterial meningitis., N. Engl. J. Med., 2007, 357, 24, 2431-2440, doi: 10.1056/NEJMoa070852.

Additional files

Editorial Notes