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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2233 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-17

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Brazil ICU Encephalitis Surveillance

NCT05370573

Encephalitis Central Nervous System Infections and Inflammations Intensive Care Neurological Disorder +3 more

COMPLETED

Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae

NCT01730690

Meningitis, Bacterial

COMPLETED

Infections of the Central Nervous System

NCT03856528

Adult Patients With Suspected Meningitis and/or Encephalitis

WITHDRAWN

Intelligent Analysis and Clinical Validation of Cerebral Small Vessel Disease on Magnetic Resonance Imaging：A Multi-center Study

NCT06667635

Cerebral Small Vessel Disease

NOT_YET_RECRUITING

Imaging SARS-CoV-2 Involvement of Leptomeninges, Olfactory and Limbic Areas

NCT04448054

Estimate, With the Contribution of Optimized MRI, the Prevalence of Neurological and Neurovascular Manifestations on Imaging in the Event of SARS-CoV-2

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Meningitis Encephalitis Abscess Brain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Baseline (pre-intervention)

Current routine care

No interventions assigned to this group

Post-intervention

Care following development and delivery of the system-level intervention

Pragmatic, multi-component package

Intervention Type OTHER

This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No