Clinical trial NCT04190303: BIGlobal Intervention Study: Improving Diagnosis and Management of Suspected Brain Infections Globally
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningitis
Encephalitis
Abscess Brain
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Christian Medical College, Vellore, India
name: National Institute of Mental Health and Neuro Sciences, India
name: Oswaldo Cruz Foundation
name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
name: Kamuzu University of Health Sciences
name: University of Warwick
name: Liverpool School of Tropical Medicine
First posted: 2019-12-09
Enrollment: 2233
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to a study hospital with symptoms and/or signs suggestive of an acute brain infection.

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.


Eligibility 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.

Primary outcomes:
measure: Microbiological diagnosis
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Syndromic diagnosis
timeFrame: During hospital admission, or at 30 days if participant still in hospital
Secondary outcomes:
measure: Proportion receiving, and time to lumbar puncture
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Proportion having appropriate cerebrospinal fluid investigations
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Mortality
timeFrame: At 30 days
measure: Length of stay in hospital
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Time to appropriate empirical therapy
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Time to appropriate definitive therapy
timeFrame: During hospital admission, or at 30 days if participant still in hospital
measure: Quality of life score
timeFrame: At hospital discharge, or at 30 days if participant still in hospital
measure: Quality of life score
timeFrame: At 30 days after presentation to hospital
measure: Liverpool Outcome Score
timeFrame: At hospital discharge, or at 30 days if participant still in hospital
measure: Liverpool Outcome Score
timeFrame: At 30 days after presentation to hospital
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: FioCruz
city: Bangalore
country: India
facility: National Institute of Mental Health and Neurosciences
city: Vellore
country: India
facility: Christian Medical College
city: Blantyre
country: Malawi
facility: Malawi Liverpool Wellcome Trust
Study officials:
affiliation: Institute of Infection & Global Health, University of Liverpool
name: Tom Solomon, PhD
role: PRINCIPAL_INVESTIGATOR
References: