Condition category
Infections and Infestations
Date applied
29/11/2005
Date assigned
20/12/2005
Last edited
04/07/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.medcol.mw/

Funders

Funder type

Charity

Funder name

Meningitis Research Foundation (United Kingdom)

Alternative name(s)

MRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21334262

Publication citations

  1. 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.

Additional files

Editorial Notes