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 |
| Secondary identifying numbers | P.98/99/30R |
- Submission date
- 16/08/2005
- Registration date
- 07/09/2005
- Last edited
- 18/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Matthew Scarborough
Scientific
Scientific
27 Oatlands Rd
Oxford
OX2 0EU
United Kingdom
| mattscar@talktalk.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone, ceftriaxione |
| Primary outcome measure | 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 study start date | 15/05/2002 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- Malawi
- United Kingdom
Study participating centre
27 Oatlands Rd
Oxford
OX2 0EU
United Kingdom
OX2 0EU
United Kingdom
Sponsor information
College of Medicine Research Committee (Malawi)
University/education
University/education
Private Bag 360
Chichiri
Blantyre
BT3
Malawi
"ROR" |
https://ror.org/04vtx5s55 |
|---|
Funders
Funder type
Charity
Meningitis Research Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- MRF
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 13/12/2007 | Yes | No |
