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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190303
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : October 1, 2021
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Tom Solomon, University of Liverpool

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Meningitis Encephalitis Abscess Brain Other: Pragmatic, multi-component package

Study Design
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Study Type : Observational
Estimated Enrollment : 3600 participants
Observational Model: Other
Time Perspective: Prospective
Official 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
Actual Study Start Date : February 17, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Baseline (pre-intervention)
Current routine care
Post-intervention
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients presenting to a study hospital with symptoms and/or signs suggestive of an acute brain infection.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04190303


Contacts
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Contact: Bhagteshwar Singh, MBChB +441517957577 bsingh@liverpool.ac.uk

Locations
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Brazil
FioCruz Recruiting
Recife, Brazil
Contact: Rafael Franca         
India
National Institute of Mental Health and Neurosciences Recruiting
Bangalore, India
Contact: Anita Desai         
Christian Medical College Recruiting
Vellore, India
Contact: Priscilla Rupali         
Malawi
Malawi Liverpool Wellcome Trust Recruiting
Blantyre, Malawi
Contact: Jen Cornick         
Sponsors and Collaborators
University of Liverpool
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
Investigators
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Principal Investigator: Tom Solomon, PhD Institute of Infection & Global Health, University of Liverpool
More Information
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Responsible Party: Tom Solomon, Professor, University of Liverpool
ClinicalTrials.gov Identifier: NCT04190303    
Other Study ID Numbers: UoL001430 - 4069
First Posted: December 9, 2019    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Meningitis
Encephalitis
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases