Randomised controlled trial of glycerol adjuvant therapy in adult bacterial meningitis in Malawi
| ISRCTN | ISRCTN70121840 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70121840 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/11/2005
- Registration date
- 20/12/2005
- Last edited
- 04/07/2011
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Katherine Ajdukiewicz
Scientific
Scientific
Dept of Medicine
Queen Elizabeth Central Hospital
Blantyre
BT3
Malawi
| Phone | +265 9358501 |
|---|---|
| katherineaz@doctors.org.uk |
Study information
| Study design | Double-blind placebo-controlled randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GLAM |
| Study objectives | Glycerol adjuvant therapy improves outcome in adult patients with bacterial meningitis |
| Ethics approval(s) | 1. College of Medicine Research and Ethics Committee (COMREC), University of Malawi, Malawi, approved in January 2006 2. Liverpool School of Tropical Medicine, UK, approved in February 2006 (ref: 05/64A) |
| Health condition(s) or problem(s) studied | Meningitis |
| Intervention | This trial was stopped in August 2008 following a planned (unblinded) interim analysis due to safety issues. In total 265 patients were randomised. Phase I - Forty five patients will be recruited for assessment of glycerol tolerability. Fifteen patients each will receive glycerol at a dose of 25 ml twice a day (bd), 25 ml four times a day (qds) or 50 ml qds for four days. Phase II - Patients will be randomised by computer generated permuted blocks to receive glycerol adjuvant therapy at the highest tolerated dose, or equivalent volume of 50% dextrose, for four days. All patients will receive bacterial meningitis treatment, in Malawi the standard guidelines are with parenteral penicillin and chloramphenicol for a minimum of 10 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Glycerol |
| Primary outcome measure | Phase I: Tolerability of glycerol adjuvant therapy and serious adverse events Phase II: Death by 1 month |
| Secondary outcome measures | 1. Physician decision to alter treatment based on the occurrence of complications 2. Death or residual neurological deficit (Glasgow Outcome Score and hearing loss) at discharge, and one month after completing antibiotic therapy 3. Time to death, time to discharge 4. Effect of glycerol on change in CSF pressure. We will also aim to perform a sub-study on a limited set of patients to gain data on CSF penetration of glycerol. |
| Overall study start date | 05/01/2006 |
| Completion date | 30/12/2009 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 500 |
| Key inclusion criteria | 1. Patients >=16 years old admitted with headache, fever and neck stiffness AND cerebrospinal fluid (CSF) findings suggestive of bacterial meningitis, defined as: cloudy CSF in a patient requiring immediate treatment or greater than 100 white cells/ml in the CSF with predominant neutrophils or gram-stain showing bacteria 2. Informed consent given (or in the case of unconscious patients, their guardian on their behalf), patient willing to follow study protocol |
| Key exclusion criteria | 1. Pregnant females 2. Type II diabetics 3. Patients with heart failure 4. Patients whose CSF results indicate infection by cryptococcus or mycobacteria |
| Date of first enrolment | 05/01/2006 |
| Date of final enrolment | 30/12/2009 |
Locations
Countries of recruitment
- Malawi
Study participating centre
Dept of Medicine
Blantyre
BT3
Malawi
BT3
Malawi
Sponsor information
University of Malawi, College of Medicine (Malawi)
University/education
University/education
EE Zijlstra
Blantyre
BT3
Malawi
| eezijlstra@malawi.net | |
| Website | http://www.medcol.mw/ |
"ROR" |
https://ror.org/04vtx5s55 |
Funders
Funder type
Charity
Meningitis Research Foundation (United Kingdom)
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 | 01/04/2011 | Yes | No |
