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NCT Number: NCT05496673

Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda

This study will investigate the burden, causes, diagnostics, treatments and preventive measures related to meningitis in northern Uganda. We hypothesize that understanding the burden of meningitis, risk factors, diagnostics, treatments and the preventive measures will provide information regarding the gaps in care that can be addressed in order to improve the continuum of meningitis care. we hypothesize that our data will support the advocacy for the implementation of routine vaccination for the prevention of bacterial meningitis and improving guidelines for Cryptococcal antigen (CrAg) screening for prevention of cryptococcal meningitis, which will save lives in Uganda.

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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Key information

Conditions

Meningitis Nervous System Diseases Neuroinflammatory Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1100 patients who present with meningitis or meningitis symptoms, regardless of age or vulnerably status are eligible for meningitis testing.
  • 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

  • Patients who are found not to have meningitis after initial evaluation, or are found to have other alternative diagnoses that explain their symptoms, will be excluded.
  • HIV-negative patients without signs or symptoms of meningitis.

Treatment and study plan

Pastorex Latex Agglutination Test

Diagnostic Test

Rapid diagnosis of bacterial meningitis

Biofire PCR for meningitis

Diagnostic Test

Rapid diagnosis of multiple forms of meningitis

Immy CrAg Lateral Flow Assay

Diagnostic Test

Rapid diagnosis of cryptococcal meningitis

Primary outcomes

  1. number of participants with meningitis who died during hospitalization

    Time frame: duration of hospitalization, approximately 2 weeks

  2. number of participants with meningitis who died during the first 24 months after hospital admission

    Time frame: 24 months

  3. number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive

    Time frame: 2 years

Secondary outcomes

  1. number of participants who develop overt cryptococcal meningitis

    Time frame: 2 years

    Overt cryptococcal meningitis is defined as symptomatic meningitis.

  2. Number of participants with overt cryptococcal meningitis who die

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Bohjanen, MD

CONTACT

[email protected]

585-275-5871

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • Lira University
  • Makerere University

Registry information

Important dates

Study start
2022
Primary completion
2031
Study completion
2031
First posted
Aug 11, 2022
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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