Clinical trial NCT05496673: Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
Official title: Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meningitis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Lira University
name: Fogarty International Center of the National Institute of Health
name: Makerere University
First posted: 2022-08-11
Enrollment: 11100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Primary outcomes:
measure: number of participants with meningitis who died during hospitalization
timeFrame: duration of hospitalization, approximately 2 weeks
measure: number of participants with meningitis who died during the first 24 months after hospital admission
timeFrame: 24 months
measure: number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive
timeFrame: 2 years
Secondary outcomes:
measure: number of participants who develop overt cryptococcal meningitis
timeFrame: 2 years
measure: Number of participants with overt cryptococcal meningitis who die
timeFrame: 2 years
Other outcomes:
Locations:
city: Lira
country: Uganda
facility: Lira Regional Referral Hospital
Study officials:
References: