Trials / Recruiting
RecruitingNCT05496673
Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11,100 (estimated)
- Sponsor
- University of Rochester · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-09-01
- Primary completion
- 2031-09-01
- Completion
- 2031-09-01
- First posted
- 2022-08-11
- Last updated
- 2026-01-12
Locations
1 site across 1 country: Uganda
Source: ClinicalTrials.gov record NCT05496673. Inclusion in this directory is not an endorsement.