An interventional study of Pastorex Latex Agglutination Test and Biofire PCR for meningitis in Meningitis, sponsored by University of Rochester. Recruiting at 1 site in Uganda. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by University of Rochester · Not applicable, Interventional, and Diagnostic
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.
268 studies on the registry are indexed under Meningitis; 28 are open to participants now.
This study's planned enrollment of 11,100 is above the median of 260 across 185 interventional studies indexed under Meningitis.
Browse Meningitis studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Pastorex Latex Agglutination Test · Diagnostic Test: Biofire PCR for meningitis · Diagnostic Test: Immy CrAg Lateral Flow Assay
Rapid diagnosis of bacterial meningitis
Rapid diagnosis of multiple forms of meningitis
Rapid diagnosis of cryptococcal meningitis
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
number of participants who develop overt cryptococcal meningitis
Overt cryptococcal meningitis is defined as symptomatic meningitis.
Time frame: 2 years
Number of participants with overt cryptococcal meningitis who die
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Sep 2031, 108 months after the start.
Of 24 interventional studies with no phase under Meningitis, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's planned 108 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.