We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04190303
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : October 1, 2021
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
Christian Medical College, Vellore, India
National Institute of Mental Health and Neuro Sciences, India
Oswaldo Cruz Foundation
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Kamuzu University of Health Sciences
University of Warwick
Liverpool School of Tropical Medicine
Information provided by (Responsible Party):
Tom Solomon, University of Liverpool

Tracking Information
First Submitted Date December 1, 2019
First Posted Date December 9, 2019
Last Update Posted Date October 1, 2021
Actual Study Start Date February 17, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 4, 2019)
  • Microbiological diagnosis [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Proportion of patients achieving microbiological diagnosis
  • Syndromic diagnosis [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Proportion of patients achieving syndromic diagnosis
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 4, 2019)
  • Proportion receiving, and time to lumbar puncture [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Proportion of study participants receiving a lumbar puncture, and time to lumbar puncture
  • Proportion having appropriate cerebrospinal fluid investigations [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    All of: cell count, total and differential; CSF protein concentration; CSF glucose concentration; paired serum/blood glucose concentration; microscopy and culture for bacteria
  • Mortality [ Time Frame: At 30 days ]
    All-cause
  • Length of stay in hospital [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Duration of hospital admission
  • Time to appropriate empirical therapy [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Time to appropriate empirical anti-infective therapy
  • Time to appropriate definitive therapy [ Time Frame: During hospital admission, or at 30 days if participant still in hospital ]
    Time to appropriate definitive anti-infective therapy
  • Quality of life score [ Time Frame: At hospital discharge, or at 30 days if participant still in hospital ]
    Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.
  • Quality of life score [ Time Frame: At 30 days after presentation to hospital ]
    Using EuroQol EQ-5D questionnaires scoring 5 domains at levels 1-3 each, and an overall health state from 0 to 100.
  • Liverpool Outcome Score [ Time Frame: At hospital discharge, or at 30 days if participant still in hospital ]
    Score measuring neurological function after brain infection, reporting a lowest score of 15 domains between 2 and 5, and a total score with range 33-75.
  • Liverpool Outcome Score [ Time Frame: At 30 days after presentation to hospital ]
    Score measuring neurological function after brain infection, reporting a lowest score of 15 domains between 2 and 5, and a total score with range 33-75.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients presenting to a study hospital with symptoms and/or signs suggestive of an acute brain infection.
Condition
  • Meningitis
  • Encephalitis
  • Abscess Brain
Intervention 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
Study Groups/Cohorts
  • Baseline (pre-intervention)
    Current routine care
  • Post-intervention
    Care following development and delivery of the system-level intervention
    Intervention: Other: Pragmatic, multi-component package
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 4, 2019)
3600
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bhagteshwar Singh, MBChB +441517957577 bsingh@liverpool.ac.uk
Listed Location Countries Brazil,   India,   Malawi
Removed Location Countries  
 
Administrative Information
NCT Number NCT04190303
Other Study ID Numbers UoL001430 - 4069
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Tom Solomon, University of Liverpool
Original Responsible Party Same as current
Current Study Sponsor University of Liverpool
Original Study Sponsor Same as current
Collaborators
  • National Institute for Health Research, United Kingdom
  • Christian Medical College, Vellore, India
  • National Institute of Mental Health and Neuro Sciences, India
  • Oswaldo Cruz Foundation
  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme
  • Kamuzu University of Health Sciences
  • University of Warwick
  • Liverpool School of Tropical Medicine
Investigators
Principal Investigator: Tom Solomon, PhD Institute of Infection & Global Health, University of Liverpool
PRS Account University of Liverpool
Verification Date September 2021