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

Meningitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05496673
• Other study ID #: STUDY00007296
• Secondary ID: R21TW012439
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: August 2023
• Source: University of Rochester
• Contact: Paul Bohjanen, MD
• Email: paul_bohjanen[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 all 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10400
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

Inclusion Criteria:

• All patients who present with meningitis or meningitis symptoms, regardless of age or vulnerably status is eligible for meningitis testing.
• Approximately 10,000 HIV-infected patients presenting to the LRRH HIV Clinic (LIDC), 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.
• CrAg-negative HIV-infected patients who have other active opportunistic infections will be excluded from enrollment in the control group.

Related Conditions & MeSH terms

• Meningitis

Intervention

Diagnostic Test:
• Pastorex Latex Agglutination Test
Rapid diagnosis of bacterial meningitis
• Biofire PCR for meningitis
Rapid diagnosis of multiple forms of meningitis
• Immy CrAg Lateral Flow Assay
Rapid diagnosis of cryptococcal meningitis

Locations

Country	Name	City	State
Uganda	Lira Regional Referral Hospital	Lira

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	Fogarty International Center of the National Institute of Health, Infectious Disease Institute at Makerere University, Lira University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with meningitis who died during hospitalization		duration of hospitalization, approximately 2 weeks
Primary	number of participants with meningitis who died during the first 6 months of hospital admission		6 months
Primary	number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive		2 years
Secondary	number of participants who develop overt cryptococcal meningitis	Overt cryptococcal meningitis is defined as symptomatic meningitis.	2 years
Secondary	Number of participants with overt cryptococcal meningitis who die		2 years