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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04190303
• Other study ID #: UoL001430 - 4069
• Status: Active, not recruiting
• Start date: February 17, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2230
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

• Abscess Brain
• Encephalitis
• Meningitis

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

Locations

Country	Name	City	State
Brazil	FioCruz	Recife
India	National Institute of Mental Health and Neurosciences	Bangalore
India	Christian Medical College	Vellore
Malawi	Malawi Liverpool Wellcome Trust	Blantyre

Sponsors (9)

Lead Sponsor	Collaborator
University of Liverpool	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

Countries where clinical trial is conducted

Brazil,  India,  Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological diagnosis	Proportion of patients achieving microbiological diagnosis	During hospital admission, or at 30 days if participant still in hospital
Primary	Syndromic diagnosis	Proportion of patients achieving syndromic diagnosis	During hospital admission, or at 30 days if participant still in hospital
Secondary	Proportion receiving, and time to lumbar puncture	Proportion of study participants receiving a lumbar puncture, and time to lumbar puncture	During hospital admission, or at 30 days if participant still in hospital
Secondary	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	During hospital admission, or at 30 days if participant still in hospital
Secondary	Mortality	All-cause	At 30 days
Secondary	Length of stay in hospital	Duration of hospital admission	During hospital admission, or at 30 days if participant still in hospital
Secondary	Time to appropriate empirical therapy	Time to appropriate empirical anti-infective therapy	During hospital admission, or at 30 days if participant still in hospital
Secondary	Time to appropriate definitive therapy	Time to appropriate definitive anti-infective therapy	During hospital admission, or at 30 days if participant still in hospital
Secondary	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.	At hospital discharge, or at 30 days if participant still in hospital
Secondary	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.	At 30 days after presentation to hospital
Secondary	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.	At hospital discharge, or at 30 days if participant still in hospital
Secondary	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.	At 30 days after presentation to hospital