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

NCT05496673 | Recruiting

• 2 other identifiers: STUDY00007296R21TW012439
• Study Type: interventional
• Target: 11,100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningitis

Outcome Measures

Primary Outcomes (3)

• number of participants with meningitis who died during hospitalization

  duration of hospitalization, approximately 2 weeks

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

  24 months

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

  2 years

Secondary Outcomes (2)

• number of participants who develop overt cryptococcal meningitis

  2 years

• Number of participants with overt cryptococcal meningitis who die

  2 years

Study Arms (1)

Participants with meningitis or risk factors for meningitis

EXPERIMENTAL

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; Diagnostic Test: Biofire PCR for meningitis; Diagnostic Test: Immy CrAg Lateral Flow Assay

Interventions

Pastorex Latex Agglutination Test DIAGNOSTIC_TEST

Rapid diagnosis of bacterial meningitis

Participants with meningitis or risk factors for meningitis

Biofire PCR for meningitis DIAGNOSTIC_TEST

Rapid diagnosis of multiple forms of meningitis

Participants with meningitis or risk factors for meningitis

Immy CrAg Lateral Flow Assay DIAGNOSTIC_TEST

Rapid diagnosis of cryptococcal meningitis

Participants with meningitis or risk factors for meningitis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Lira University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• Makerere University: collaborator

Study Sites (1)

Lira Regional Referral Hospital

Lira, 224180000, Uganda

RECRUITING

MeSH Terms

Conditions

Meningitis

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases

Central Study Contacts

Paul Bohjanen, MD

CONTACT

585-275-5871; paul_bohjanen@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 11, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)