An observational study in Meningitis, Encephalitis and Abscess Brain, sponsored by University of Liverpool. Completed at 4 sites in 3 countries. Open to participants aged 4 Weeks and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by University of Liverpool · Observational
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.
373 studies on the registry are indexed under Meningitis; 32 are open to participants now.
This study's enrollment of 2,233 is above the median of 340 across 95 observational studies indexed under Meningitis.
Browse Meningitis studies →University of Liverpool is the lead sponsor of 99 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to a study hospital with symptoms and/or signs suggestive of an acute brain infection.
Exclusion Criteria:
Current routine care
Care following development and delivery of the system-level intervention
Other: Pragmatic, 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
Microbiological diagnosis
Proportion of patients achieving microbiological diagnosis
Time frame: During hospital admission, or at 30 days if participant still in hospital
Syndromic diagnosis
Proportion of patients achieving syndromic diagnosis
Time frame: During hospital admission, or at 30 days if participant still in hospital
Proportion receiving, and time to lumbar puncture
Proportion of study participants receiving a lumbar puncture, and time to lumbar puncture
Time frame: During hospital admission, or at 30 days if participant still in hospital
Proportion having appropriate cerebrospinal fluid investigations
All of: cell count, total and differential; CSF protein concentration; CSF glucose concentration; paired serum/blood glucose concentration; microscopy and culture for bacteria
Time frame: During hospital admission, or at 30 days if participant still in hospital
Mortality
All-cause
Time frame: At 30 days
Length of stay in hospital
Duration of hospital admission
Time frame: During hospital admission, or at 30 days if participant still in hospital
Time to appropriate empirical therapy
Time to appropriate empirical anti-infective therapy
Time frame: During hospital admission, or at 30 days if participant still in hospital
Time to appropriate definitive therapy
Time to appropriate definitive anti-infective therapy
Time frame: During hospital admission, or at 30 days if participant still in hospital
Quality of life score
Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.
Time frame: At hospital discharge, or at 30 days if participant still in hospital
Quality of life score
Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.
Time frame: At 30 days after presentation to hospital
Liverpool Outcome Score
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 frame: At hospital discharge, or at 30 days if participant still in hospital
Liverpool Outcome Score
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 frame: At 30 days after presentation to hospital
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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