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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW012439 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Lira University | OTHER |
| Fogarty International Center of the National Institute of Health | NIH |
| Makerere University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pastorex Latex Agglutination Test | Diagnostic Test | Rapid diagnosis of bacterial meningitis |
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| Measure | Description | Time Frame |
|---|---|---|
| number of participants with meningitis who died during hospitalization | duration of hospitalization, approximately 2 weeks | |
| number of participants with meningitis who died during the first 24 months after hospital admission | 24 months | |
| number of participants who were screened using the CrAg diagnostic test who were cryptococcal antigen positive | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants who develop overt cryptococcal meningitis | Overt cryptococcal meningitis is defined as symptomatic meningitis. | 2 years |
| Number of participants with overt cryptococcal meningitis who die |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Bohjanen, MD | Contact | 585-275-5871 | paul_bohjanen@urmc.rochester.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lira Regional Referral Hospital | Recruiting | Lira | 224180000 | Uganda |
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| ID | Term |
|---|---|
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
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| Biofire PCR for meningitis | Diagnostic Test | Rapid diagnosis of multiple forms of meningitis |
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| Immy CrAg Lateral Flow Assay | Diagnostic Test | Rapid diagnosis of cryptococcal meningitis |
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| 2 years |