Double blind placebo controlled trial of steroids in Bacterial Meningitis
| ISRCTN | ISRCTN42986828 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42986828 |
| Secondary identifying numbers | 061330 |
- Submission date
- 22/07/2005
- Registration date
- 22/07/2005
- Last edited
- 28/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jeremy Farrar
Scientific
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 |
|---|---|
| jfarrar@oucru.org |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethazone |
| Primary outcome measure | Mortality |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/11/1996 |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | To be added |
| 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 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Hospital for Tropical Diseases
Ho Chi Minh City
5
Viet Nam
5
Viet Nam
Sponsor information
University of Oxford (UK)
University/education
University/education
University Offices
Wellington Square
Oxford
OX1 2JD
England
United Kingdom
| Website | http://www.ox.ac.uk |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Charity
The Wellcome Trust (UK) (grant ref: 061330)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| 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 |
Editorial Notes
28/10/2022: Internal review.
