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.

Study Overview

• Status: Recruiting
• Conditions: Meningitis
• Intervention / Treatment: Diagnostic test: Pastorex Latex Agglutination Test; Diagnostic test: Biofire PCR for meningitis; Diagnostic test: Immy CrAg Lateral Flow Assay

• Study Type: Interventional
• Enrollment (Estimated): 11100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paul Bohjanen, MD; Phone Number: 585-275-5871; Email: paul_bohjanen@urmc.rochester.edu

Study Locations

• Uganda
  • Lira, Uganda, 224180000
    • Recruiting
    • Lira Regional Referral Hospital
    • Contact: Mark Okwir, MBChB, MMED; Phone Number: 256-782352356; Email: markdr111@gmail.com
    • Contact: Abigail Link, RN, MPH, PhD; Phone Number: 763-344-9231; Email: linabi12@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Diagnostic test: Pastorex Latex Agglutination Test; Rapid diagnosis of bacterial meningitis; Diagnostic test: Biofire PCR for meningitis; Rapid diagnosis of multiple forms of meningitis; Diagnostic test: Immy CrAg Lateral Flow Assay; Rapid diagnosis of cryptococcal meningitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of participants with meningitis who died during hospitalization	duration of hospitalization, approximately 2 weeks
number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive	2 years
number of participants with meningitis who died during the first 24 months after hospital admission	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants who develop overt cryptococcal meningitis	Overt cryptococcal meningitis is defined as symptomatic meningitis.	2 years
Number of participants with overt cryptococcal meningitis who die		2 years

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Fogarty International Center of the National Institute of Health; Makerere University; Lira University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Nervous System Diseases; Meningitis
• Other Study ID Numbers: STUDY00007296; R21TW012439 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No