Meningitis
Conditions
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.
Interventions
DIAGNOSTIC_TESTPastorex Latex Agglutination Test
Rapid diagnosis of bacterial meningitis
DIAGNOSTIC_TESTBiofire PCR for meningitis
Rapid diagnosis of multiple forms of meningitis
DIAGNOSTIC_TESTImmy CrAg Lateral Flow Assay
Rapid diagnosis of cryptococcal meningitis
Sponsors
University of Rochester
Lira University
Fogarty International Center of the National Institute of Health
Makerere University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| number of participants who develop overt cryptococcal meningitis | 2 years | Overt cryptococcal meningitis is defined as symptomatic meningitis. |
| Number of participants with overt cryptococcal meningitis who die | 2 years | — |
Countries
Uganda
Contacts
CONTACTPaul Bohjanen, MD
Outcome results
None listed