MeningitisNCT05496673
Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
A study testing Pastorex Latex Agglutination Test, Biofire PCR for meningitis and Immy CrAg Lateral Flow Assay in people with Meningitis, run by University of Rochester at 1 site in Uganda.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Meningitis
- What is being tested?
- Pastorex Latex Agglutination Test, Biofire PCR for meningitis and Immy CrAg Lateral Flow Assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,100 participants
- Where
- 1 siteUganda
- Study dates
- 1 Sep 2022to 1 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Lira Regional Referral Hospital
Lira, 224180000
Mark Okwir, MBChB, MMED, 256-782352356, markdr111@gmail.com
Abigail Link, RN, MPH, PhD, 763-344-9231, linabi12@gmail.com
About this study
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.
- Conditions
- Meningitis
- Being tested
- Pastorex Latex Agglutination Test, Biofire PCR for meningitis, Immy CrAg Lateral Flow Assay
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pastorex Latex Agglutination TestDiagnostic test
Rapid diagnosis of bacterial meningitis
Biofire PCR for meningitisDiagnostic test
Rapid diagnosis of multiple forms of meningitis
Immy CrAg Lateral Flow AssayDiagnostic test
Rapid diagnosis of cryptococcal meningitis
| Study group | Role | What they receive |
|---|---|---|
| Participants with meningitis or risk factors for meningitis | Experimental | 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. Receives: Diagnostic Test: Pastorex Latex Agglutination Test; Diagnostic Test: Biofire PCR for meningitis; Diagnostic Test: Immy CrAg Lateral Flow Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with meningitis who died during hospitalization
Measured: duration of hospitalization, approximately 2 weeks
number of participants with meningitis who died during the first 24 months after hospital admission
Measured: 24 months
number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive
Measured: 2 years
Secondary outcomes (2)
number of participants who develop overt cryptococcal meningitis
Overt cryptococcal meningitis is defined as symptomatic meningitis.
Measured: 2 years
Number of participants with overt cryptococcal meningitis who die
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningitisStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Lira University, Fogarty International Center of the National Institute of Health, Makerere University
- Responsible party
- Principal investigator, Paul Bohjanen, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496673
- Sponsor's protocol ID
- STUDY00007296
- Other IDs
- R21TW012439
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meningitis: Burden, Causes, Screening and Prevention in Rural Northern Uganda
- ClinicalTrials.gov ID
- NCT05496673
- Acronym / sponsor ID
- STUDY00007296
- Conditions
- Meningitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11,100 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Lira University, Fogarty International Center of the National Institute of Health, Makerere University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with meningitis or risk factors for meningitis | Experimental | Diagnostic Test: Pastorex Latex Agglutination Test, Diagnostic Test: Biofire PCR for meningitis, Diagnostic Test: Immy CrAg Lateral Flow AssayPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pastorex Latex Agglutination TestRapid diagnosis of bacterial meningitis | Diagnostic test | Participants with meningitis or risk factors for meningitis |
| Biofire PCR for meningitisRapid diagnosis of multiple forms of meningitis | Diagnostic test | Participants with meningitis or risk factors for meningitis |
| Immy CrAg Lateral Flow AssayRapid diagnosis of cryptococcal meningitis | Diagnostic test | Participants with meningitis or risk factors for meningitis |
Primary outcome
number of participants with meningitis who died during hospitalization
Time frame: duration of hospitalization, approximately 2 weeks
number of participants with meningitis who died during the first 24 months after hospital admission
Time frame: 24 months
number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive
Time frame: 2 years
2 secondary outcomes
number of participants who develop overt cryptococcal meningitis
Time frame: 2 years
Number of participants with overt cryptococcal meningitis who die
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pastorex Latex Agglutination Test, Biofire PCR for meningitis and Immy CrAg Lateral Flow Assay in people with Meningitis, run by University of Rochester at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Bohjanen, MD (585-275-5871, paul_bohjanen@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with meningitis who died during hospitalization (time frame: duration of hospitalization, approximately 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.