Randomised controlled trial of glycerol adjuvant therapy in adult bacterial meningitis in Malawi

Completed

• Conditions: Meningitis; Infections and Infestations

• Registration Number: ISRCTN70121840
• Lead Sponsor: niversity of Malawi, College of Medicine (Malawi)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 500

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

1. Pregnant females
2. Type II diabetics
3. Patients with heart failure
4. Patients whose CSF results indicate infection by cryptococcus or mycobacteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I: Tolerability of glycerol adjuvant therapy and serious adverse events<br>Phase II: Death by 1 month

Secondary Outcome Measures

Name	Time	Method
1. Physician decision to alter treatment based on the occurrence of complications<br>2. Death or residual neurological deficit (Glasgow Outcome Score and hearing loss) at discharge, and one month after completing antibiotic therapy<br>3. Time to death, time to discharge<br>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.