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NCT Number: NCT04190303

BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally

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.

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Key information

Age range

4 week and older

Sex eligibility

All sexes

Study type

Observational

Primary location

FioCruz, Recife, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Symptom duration of less than 4 weeks.

Exclusion criteria

  • Neonates, i.e. children under the age of 28 days.
  • 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).
  • People without an indwelling device, having undergone neurosurgical procedures within the preceding 12 months.

Treatment and study plan

Pragmatic, multi-component package

Other

This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff

Primary outcomes

  1. Microbiological diagnosis

    Time frame: During hospital admission, or at 30 days if participant still in hospital

    Proportion of patients achieving microbiological diagnosis

  2. Syndromic diagnosis

    Time frame: During hospital admission, or at 30 days if participant still in hospital

    Proportion of patients achieving syndromic diagnosis

Secondary outcomes

  1. Proportion receiving, and time to lumbar puncture

    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

  2. Proportion having appropriate cerebrospinal fluid investigations

    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

  3. Mortality

    Time frame: At 30 days

    All-cause

  4. Length of stay in hospital

    Time frame: During hospital admission, or at 30 days if participant still in hospital

    Duration of hospital admission

  5. Time to appropriate empirical therapy

    Time frame: During hospital admission, or at 30 days if participant still in hospital

    Time to appropriate empirical anti-infective therapy

  6. Time to appropriate definitive therapy

    Time frame: During hospital admission, or at 30 days if participant still in hospital

    Time to appropriate definitive anti-infective therapy

  7. Quality of life score

    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.

  8. Quality of life score

    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.

  9. Liverpool Outcome Score

    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.

  10. Liverpool Outcome Score

    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.

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Christian Medical College, Vellore, India
  • Kamuzu University of Health Sciences
  • Liverpool School of Tropical Medicine
  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme
  • National Institute for Health Research, United Kingdom
  • National Institute of Mental Health and Neuro Sciences, India
  • Oswaldo Cruz Foundation
  • University of Warwick

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2019
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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