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

University of Rochester

Status: Enrolling

Conditions: Meningitis

Treatments: Diagnostic Test: Pastorex Latex Agglutination Test; Diagnostic Test: Immy CrAg Lateral Flow Assay; Diagnostic Test: Biofire PCR for meningitis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05496673

R21TW012439 (U.S. NIH Grant/Contract)

STUDY00007296

Details and patient eligibility

About

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.

Enrollment: 11,100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11,100 participants in 1 patient group

Participants with meningitis or risk factors for meningitis

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Biofire PCR for meningitis

Diagnostic Test: Immy CrAg Lateral Flow Assay

Diagnostic Test: Pastorex Latex Agglutination Test