Breakthrough test could save kids from deadly TB meningitis
NCT ID NCT04308928
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to create a quick, simple test to diagnose tuberculous meningitis (TBM) in children. TBM is a severe form of TB that affects the brain and is hard to detect with current methods, especially in places with limited resources. Researchers tested 51 inflammatory markers in blood and spinal fluid from 332 children to find the best combination for a new point-of-care diagnostic device. The goal is to speed up diagnosis and reduce the high death and disability rates from this disease.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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332 people
The number who actually took part.
- Started
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Apr 2020
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will be conducted at Tygerberg Children's Hospital, Parow Valley, Cape Town. The hospital is the tertiary academic hospital of the Faculty of Medicine and Health Sciences, University of Stellenbosch. Children with tuberculous meningitis are referred from primary care day hospitals, district and secondary level hospitals from our drainage area. Children with suspected TBM are referred to our institution to establish the diagnosis of TBM and to treat the complications associated with advanced disease (stage 2 and 3 TBM, e.g. hydrocephalus). Research samples collected for the purposes of the current study shall be processed at the Stellenbosch University Immunology Research Group (SUN-IRG) laboratory, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences.
- Ages
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3 months to 13 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * Children 13 years and older will be excluded from the study. * Failure to obtain written consent will also exclude children from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stellenbosch University Immunology Research Group
Cape Town, Western Cape, 7505, South Africa
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