Pragmatic, multi-component package
OtherThis system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff
NCT Number: NCT04190303
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.
Looking for future studies?
Notify Me4 week and older
All sexes
Observational
FioCruz, Recife, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff
Time frame: During hospital admission, or at 30 days if participant still in hospital
Proportion of patients achieving microbiological diagnosis
Time frame: During hospital admission, or at 30 days if participant still in hospital
Proportion of patients achieving syndromic diagnosis
Time frame: 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
Time frame: 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
Time frame: At 30 days
All-cause
Time frame: During hospital admission, or at 30 days if participant still in hospital
Duration of hospital admission
Time frame: During hospital admission, or at 30 days if participant still in hospital
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 anti-infective therapy
Time frame: 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.
Time frame: At 30 days after presentation to hospital
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
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
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.
University of Liverpool
Other
NIHR Global Health Research Group on Brain Infections Study: Establishing a Standard Care Package to Improve Diagnosis and Early Hospital Management of Patients With Suspected Acute Brain Infections in Low and Middle Income Countries
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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