Health Trials

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

ConditionMeningitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Rochester

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pastorex Latex Agglutination Test

    Diagnostic test

    Rapid diagnosis of bacterial meningitis

  • Biofire PCR for meningitis

    Diagnostic test

    Rapid diagnosis of multiple forms of meningitis

  • Immy CrAg Lateral Flow Assay

    Diagnostic test

    Rapid diagnosis of cryptococcal meningitis

Treatment groups

11,100 Participants
are divided into 1 treatment group
Group A: Participants with meningitis or risk factors for meningitisExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

number of participants with meningitis who died during hospitalization

Time frame
duration of hospitalization, approximately 2 weeks
2

number of participants with meningitis who died during the first 24 months after hospital admission

Time frame
24 months
3

number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive

Time frame
2 years

Secondary outcomes

1

number of participants who develop overt cryptococcal meningitis

Overt cryptococcal meningitis is defined as symptomatic meningitis.

Time frame
2 years
2

Number of participants with overt cryptococcal meningitis who die

Time frame
2 years

Other outcomes

Sponsors and contacts

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University of Rochester

Lead sponsor

Lira University

Collaborator

Fogarty International Center of the National Institute of Health

Collaborator

Makerere University

Collaborator

Source ClinicalTrials.gov
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