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

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

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

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Christian Medical College, Vellore, India

  collaborator OTHER

• National Institute of Mental Health and Neuro Sciences, India

  collaborator OTHER

• Oswaldo Cruz Foundation

  collaborator OTHER

• Malawi-Liverpool-Wellcome Trust Clinical Research Programme

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• University of Warwick

  collaborator OTHER

• Liverpool School of Tropical Medicine

  collaborator OTHER

• University of Liverpool

  lead OTHER

Principal Investigators

• Tom Solomon, PhD · Institute of Infection & Global Health, University of Liverpool

Eligibility

Min Age

4 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-17

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Brazil
• India
• Malawi

Study Locations