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

NCT ID: NCT05496673

Last Updated: 2026-01-12

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

11100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2031-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Meningitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Pastorex Latex Agglutination Test

Intervention Type DIAGNOSTIC_TEST

Rapid diagnosis of bacterial meningitis

Biofire PCR for meningitis

Intervention Type DIAGNOSTIC_TEST

Rapid diagnosis of multiple forms of meningitis

Immy CrAg Lateral Flow Assay

Intervention Type DIAGNOSTIC_TEST

Rapid diagnosis of cryptococcal meningitis

Interventions

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Pastorex Latex Agglutination Test

Rapid diagnosis of bacterial meningitis

Intervention Type DIAGNOSTIC_TEST

Biofire PCR for meningitis

Rapid diagnosis of multiple forms of meningitis

Intervention Type DIAGNOSTIC_TEST

Immy CrAg Lateral Flow Assay

Rapid diagnosis of cryptococcal meningitis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lira University

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

Makerere University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Paul Bohjanen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lira Regional Referral Hospital

Lira, , Uganda

Site Status RECRUITING

Countries

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Uganda

Central Contacts

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Paul Bohjanen, MD

Role: CONTACT

585-275-5871

Facility Contacts

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Mark Okwir, MBChB, MMED

Role: primary

256-782352356

Abigail Link, RN, MPH, PhD

Role: backup

763-344-9231

Other Identifiers

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R21TW012439

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007296

Identifier Type: -

Identifier Source: org_study_id

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