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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Uganda
Lira Regional Referral Hospital
RECRUITING
Lira
Contact Information
Primary
Paul Bohjanen, MD
paul_bohjanen@urmc.rochester.edu
585-275-5871
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2031-09-01
Participants
Target number of participants: 11100
Treatments
Experimental: Participants with meningitis or risk factors for meningitis
Patients who are assessed at outpatient clinics near Lira, Uganda, Lira Regional Referral Hospital emergency room or are admitted to 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) or are deemed at risk for meningitis will be approached to participate in the study. Experimental molecular diagnostic testing such as cryptococcal antigen lateral flow assay, Pastorex antigen agglutination assay and/or Biofire PCR assay will be performed based on HIV status and a clinical assessment identify infectious agents.
Sponsors
Collaborators: Makerere University, Lira University, Fogarty International Center of the National Institute of Health
Leads: University of Rochester

This content was sourced from clinicaltrials.gov

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