Abscess Brain, Encephalitis, Meningitis
Conditions
Brief summary
Background: Patients with suspected brain infections pose major challenges to low and middle income countries, including their disproportionately high burden, diverse causes with inadequate surveillance, requirement for invasive and expensive tests, and the difficulty of management without a clear diagnosis. This is all compounded by resource and system constraints. Few studies have attempted to improve the care of these people in resource-limited settings. Aim: This study sets out to improve the diagnosis and early management of people with suspected acute (\<28 days of symptoms) brain infections in low and middle income countries, using a coordinated thematic approach. Outcomes: The primary outcome will be proportion of people with suspected acute brain infection receiving a diagnosis. Secondary outcomes will include mortality, length of stay in hospital, quality of life, degree of disability, and proportion having a lumbar puncture test. Participants: Children and adults with features consistent with an acute brain infection, including meningitis and encephalitis, will be recruited at a variety of hospitals in Brazil, India and Malawi. Study procedures: An assessment of current practice and capabilities at each hospital, including patient and sample journey observations and interviews with healthcare staff, will identify barriers to optimal care. Using this, a sustainable pragmatic multi-component intervention will be produced, with components modifiable to each hospital's needs. Outcomes will be reassessed post-intervention.
Interventions
OTHERPragmatic, multi-component package
This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff
Sponsors
National Institute for Health Research, United Kingdom
Christian Medical College, Vellore, India
National Institute of Mental Health and Neuro Sciences, India
Oswaldo Cruz Foundation
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Kamuzu University of Health Sciences
University of Warwick
Liverpool School of Tropical Medicine
University of Liverpool
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults, infants and children presenting to a study hospital with symptoms and/or signs suggestive of acute brain infection, which could be suspected encephalitis, suspected meningitis, or alternative features raising suspicion of brain infection. 2. Symptom duration of less than 4 weeks.
Exclusion criteria
1. Neonates, i.e. children under the age of 28 days. 2. People with pre-existing indwelling ventricular devices (e.g. extra-ventricular drains, ventriculo-peritoneal shunts) or other implants in contact with the meninges or brain (e.g. deep brain stimulators). 3. People without an indwelling device, having undergone neurosurgical procedures within the preceding 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological diagnosis | During hospital admission, or at 30 days if participant still in hospital | Proportion of patients achieving microbiological diagnosis |
| Syndromic diagnosis | During hospital admission, or at 30 days if participant still in hospital | Proportion of patients achieving syndromic diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | At 30 days | All-cause |
| Length of stay in hospital | During hospital admission, or at 30 days if participant still in hospital | Duration of hospital admission |
| Time to appropriate empirical therapy | During hospital admission, or at 30 days if participant still in hospital | Time to appropriate empirical anti-infective therapy |
| Proportion receiving, and time to lumbar puncture | During hospital admission, or at 30 days if participant still in hospital | Proportion of study participants receiving a lumbar puncture, and time to lumbar puncture |
| Quality of life score | At hospital discharge, or at 30 days if participant still in hospital | Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100. |
| Liverpool Outcome Score | At hospital discharge, or at 30 days if participant still in hospital | Score measuring neurological function after brain infection, reporting a lowest score of 15 domains between 2 and 5, and a total score with range 33-75. |
| Time to appropriate definitive therapy | During hospital admission, or at 30 days if participant still in hospital | Time to appropriate definitive anti-infective therapy |
| Proportion having appropriate cerebrospinal fluid investigations | During hospital admission, or at 30 days if participant still in hospital | All of: cell count, total and differential; CSF protein concentration; CSF glucose concentration; paired serum/blood glucose concentration; microscopy and culture for bacteria |
Countries
Brazil, India, Malawi
Outcome results
None listed