Status:
COMPLETED
Evaluation of New Biomarker-based Approaches for Improving the Diagnosis of Childhood Tuberculous Meningitis
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Medical Research Council, South Africa
Conditions:
Tuberculous Meningitis
Eligibility:
All Genders
3-13 years
Brief Summary
The rapid diagnosis of tuberculosis (TB) in children remains a serious challenge owing to limitations in the existing diagnostic tests. TB meningitis (TBM), an extrapulmonary form of TB, is the most s...
Detailed Description
Introduction: te ongoing research, early and cost-effective diagnostic tools for TBM are lacking. The detection of Mycobacterium tuberculosis (Mtb) in cerebrospinal fluid (CSF) is the gold standard f...
Eligibility Criteria
Inclusion
- Children between the ages of 3 months and 13 years with suspected meningitis, and who require CSF examination for routine diagnostic purposes at Tygerberg Children's Hospital.
- Written informed consent will be obtained from parents for inclusion of children 3 months to 7 years old in the study.
- If possible, assent will be obtained in those children older than 7 years who have a normal level of consciousness, i.e. a Glasgow Coma Score (GCS) of 15/15.
Exclusion
- Children 13 years and older will be excluded from the study.
- Failure to obtain written consent will also exclude children from the study.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT04308928
Start Date
April 1 2020
End Date
July 31 2025
Last Update
December 16 2025
Active Locations (1)
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1
Stellenbosch University Immunology Research Group
Cape Town, Western Cape, South Africa, 7505