NCT04190303

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,233 (actual)
• Sponsor: University of Liverpool · Academic / Other
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Meningitis
• Encephalitis
• Abscess Brain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-17
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2019-12-09
• Last updated: 2025-03-03

Locations

4 sites across 3 countries: Brazil, India, Malawi