Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pastorex Latex Agglutination Test, Biofire PCR for meningitis, Immy CrAg Lateral Flow Assay.
- Who it may be relevant to
- Registry conditions: Meningitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- number of participants with meningitis who died during hospitalization [Time frame: duration of hospitalization, approximately 2 weeks]
- number of participants with meningitis who died during the first 24 months after hospital admission [Time frame: 24 months]
- number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive [Time frame: 2 years]
Secondary outcome measures (2)
- number of participants who develop overt cryptococcal meningitis [Time frame: 2 years]
- Number of participants with overt cryptococcal meningitis who die [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Uganda · 1 center
- Lira Regional Referral Hospital — Lira
Identifiers
NCT: NCT05496673 · STUDY00007296 · R21TW012439