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

University of Liverpool

Status: Completed

Conditions: Meningitis; Abscess Brain; Encephalitis

Treatments: Other: Pragmatic, multi-component package

Study type: Observational

Funder types: Other

Identifiers

NCT04190303

UoL001430 - 4069

Details and patient eligibility

About

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.

Enrollment: 2,233 patients

Sex: All

Ages: 4+ weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

2,233 participants in 2 patient groups

Baseline (pre-intervention)

Description:

Current routine care

Post-intervention

Description:

Care following development and delivery of the system-level intervention

Treatment:

Other: Pragmatic, multi-component package