Meningitis Infections and Infestations Meningitis
Conditions
Interventions
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
Sponsors
University of Malawi, College of Medicine (Malawi)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Tolerability of glycerol adjuvant therapy and serious adverse events Phase II: Death by 1 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Malawi
Outcome results
None listed