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

Not Applicable

Recruiting

• Conditions: Meningitis
• Interventions: Diagnostic Test: Pastorex Latex Agglutination Test; Diagnostic Test: Immy CrAg Lateral Flow Assay; Diagnostic Test: Biofire PCR for meningitis

• Registration Number: NCT05496673
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Study Start: 2022-09-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-11
• Primary Completion: 2031-09-01
• Study Completion: 2031-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 11100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants who are HIV negative	Pastorex Latex Agglutination Test	Patients who are assessed at Lira Regional Referral Hospital emergency room or are admitted to the pediatric, male or female medical wards at 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) will be approached to participate in the study.
Participants who are HIV positive, CrAg positive	Immy CrAg Lateral Flow Assay	All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.
Participants who are HIV negative	Biofire PCR for meningitis	Patients who are assessed at Lira Regional Referral Hospital emergency room or are admitted to the pediatric, male or female medical wards at 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) will be approached to participate in the study.
Participants who are HIV positive, CrAg negative	Immy CrAg Lateral Flow Assay	All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test negative using the CrAg test will be included in this arm. All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with overt cryptococcal meningitis who die	2 years
number of participants who develop overt cryptococcal meningitis	2 years	Overt cryptococcal meningitis is defined as symptomatic meningitis.

Trial Locations

Locations (1)

Lira Regional Referral Hospital; 🇺🇬 Lira, Uganda