NCT05496673 Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
| NCT ID | NCT05496673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Rochester |
| Condition | Meningitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 11,100 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2031-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 11,100 participants in total. It began in 2022-09-01 with a primary completion date of 2031-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05496673 clinical trial?
This trial is open to participants of all sexes, studying Meningitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05496673 currently recruiting?
Yes, NCT05496673 is actively recruiting participants. Contact the research team at paul_bohjanen@urmc.rochester.edu for enrollment information.
Where is the NCT05496673 trial being conducted?
This trial is being conducted at Lira, Uganda.
Who is sponsoring the NCT05496673 clinical trial?
NCT05496673 is sponsored by University of Rochester. The trial plans to enroll 11,100 participants.