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

Primary Purpose

Meningitis

Status
Recruiting
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Pastorex Latex Agglutination Test
Biofire PCR for meningitis
Immy CrAg Lateral Flow Assay
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meningitis

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lira Regional Referral HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Participants who are HIV negative

Participants who are HIV positive, CrAg positive

Participants who are HIV positive, CrAg negative

Arm Description

Patients who are assessed at Lira Regional Referral Hospital emergency room or are admitted to the pediatric, male or female medical wards at 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) will be approached to participate in the study.

All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.

All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test negative using the CrAg test will be included in this arm. All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.

Outcomes

Primary Outcome Measures

number of participants with meningitis who died during hospitalization
number of participants with meningitis who died during the first 6 months of hospital admission
number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive

Secondary Outcome Measures

number of participants who develop overt cryptococcal meningitis
Overt cryptococcal meningitis is defined as symptomatic meningitis.
Number of participants with overt cryptococcal meningitis who die

Full Information

First Posted
August 9, 2022
Last Updated
August 30, 2023
Sponsor
University of Rochester
Collaborators
Fogarty International Center of the National Institute of Health, Infectious Disease Institute at Makerere University, Lira University
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1. Study Identification

Unique Protocol Identification Number
NCT05496673
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Fogarty International Center of the National Institute of Health, Infectious Disease Institute at Makerere University, Lira University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants who are HIV negative
Arm Type
Experimental
Arm Description
Patients who are assessed at Lira Regional Referral Hospital emergency room or are admitted to the pediatric, male or female medical wards at 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) will be approached to participate in the study.
Arm Title
Participants who are HIV positive, CrAg positive
Arm Type
Experimental
Arm Description
All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.
Arm Title
Participants who are HIV positive, CrAg negative
Arm Type
Sham Comparator
Arm Description
All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test negative using the CrAg test will be included in this arm. All HIV-infected patients of any age, who receive care at the Lira Infectious Disease Center will be approached for screening for cryptococcal antigen. Those who test positive using the CrAg test will be included in this arm.
Intervention Type
Diagnostic Test
Intervention Name(s)
Pastorex Latex Agglutination Test
Intervention Description
Rapid diagnosis of bacterial meningitis
Intervention Type
Diagnostic Test
Intervention Name(s)
Biofire PCR for meningitis
Intervention Description
Rapid diagnosis of multiple forms of meningitis
Intervention Type
Diagnostic Test
Intervention Name(s)
Immy CrAg Lateral Flow Assay
Intervention Description
Rapid diagnosis of cryptococcal meningitis
Primary Outcome Measure Information:
Title
number of participants with meningitis who died during hospitalization
Time Frame
duration of hospitalization, approximately 2 weeks
Title
number of participants with meningitis who died during the first 6 months of hospital admission
Time Frame
6 months
Title
number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive
Time Frame
2 years
Secondary Outcome Measure Information:
Title
number of participants who develop overt cryptococcal meningitis
Description
Overt cryptococcal meningitis is defined as symptomatic meningitis.
Time Frame
2 years
Title
Number of participants with overt cryptococcal meningitis who die
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Bohjanen, MD
Email
paul_bohjanen@urmc.rochester.edu
Facility Information:
Facility Name
Lira Regional Referral Hospital
City
Lira
ZIP/Postal Code
224180000
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Kumakech, PhD
Email
edward.kumakech77@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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