Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
NCT ID: NCT05496673
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
11100 participants
INTERVENTIONAL
2022-09-01
2031-09-01
Brief Summary
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Aim 1: To prospectively collect data on 1100 patients with meningitis and meningitis symptoms who were admitted to Lira Regional Referral Hospital (LRRH) to assess burden, etiologies, pathogenesis, and outcomes of meningitis using modern diagnostic testing not previously available in Uganda.
Aim 2: To perform CrAg screening of 10,000 HIV-positive patients to determine the prevalence of cryptococcal antigenemia (infection) and conduct a case control study to compare risk factors and outcomes among CrAg-positive patients and matched CrAg-negative controls based on age, sex, TB status, ART experience, CD4 count, and viral load.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with meningitis or risk factors for meningitis
Patients who are assessed at outpatient clinics near Lira, Uganda, Lira Regional Referral Hospital emergency room or are admitted to Lira Regional Referral Hospital with meningitis symptoms (defined as headache or irritability in combination with fever, confusion or Glasgow coma scale (GCS) \<14, photophobia, neck pain/stiffness, seizure or bulging fontanel) or are deemed at risk for meningitis will be approached to participate in the study. Experimental molecular diagnostic testing such as cryptococcal antigen lateral flow assay, Pastorex antigen agglutination assay and/or Biofire PCR assay will be performed based on HIV status and a clinical assessment identify infectious agents.
Pastorex Latex Agglutination Test
Rapid diagnosis of bacterial meningitis
Biofire PCR for meningitis
Rapid diagnosis of multiple forms of meningitis
Immy CrAg Lateral Flow Assay
Rapid diagnosis of cryptococcal meningitis
Interventions
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Pastorex Latex Agglutination Test
Rapid diagnosis of bacterial meningitis
Biofire PCR for meningitis
Rapid diagnosis of multiple forms of meningitis
Immy CrAg Lateral Flow Assay
Rapid diagnosis of cryptococcal meningitis
Eligibility Criteria
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Inclusion Criteria
* 10,000 HIV-infected patients presenting to LRRH, LRRH HIV Clinic (LIDC) or nearby outpatient clinics, regardless of age or vulnerability status, are eligible for CrAg screening.
Exclusion Criteria
* HIV-negative patients without signs or symptoms of meningitis.
ALL
No
Sponsors
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Lira University
OTHER
Fogarty International Center of the National Institute of Health
NIH
Makerere University
OTHER
University of Rochester
OTHER
Responsible Party
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Paul Bohjanen
Professor
Locations
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Lira Regional Referral Hospital
Lira, , Uganda
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00007296
Identifier Type: -
Identifier Source: org_study_id
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