Contact information
Type
Scientific
Primary contact
Dr Katherine Ajdukiewicz
ORCID ID
Contact details
Dept of Medicine
Queen Elizabeth Central Hospital
Blantyre
BT3
Malawi
+265 9358501
katherineaz@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
GLAM
Study hypothesis
Glycerol adjuvant therapy improves outcome in adult patients with bacterial meningitis
Ethics approval
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)
Study design
Double-blind placebo-controlled randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
05/01/2006
Overall trial end date
30/12/2009
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant 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
Recruitment start date
05/01/2006
Recruitment end date
30/12/2009
Locations
Countries of recruitment
Malawi
Trial participating centre
Dept of Medicine
Blantyre
BT3
Malawi
Sponsor information
Organisation
University of Malawi, College of Medicine (Malawi)
Sponsor details
EE Zijlstra
Blantyre
BT3
Malawi
eezijlstra@malawi.net
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Meningitis Research Foundation (United Kingdom)
Alternative name(s)
MRF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21334262
Publication citations
-
Results
Ajdukiewicz KM, Cartwright KE, Scarborough M, Mwambene JB, Goodson P, Molyneux ME, Zijlstra EE, French N, Whitty CJ, Lalloo DG, Glycerol adjuvant therapy in adults with bacterial meningitis in a high HIV seroprevalence setting in Malawi: a double-blind, randomised controlled trial., Lancet Infect Dis, 2011, 11, 4, 293-300, doi: 10.1016/S1473-3099(10)70317-0.