Status:
COMPLETED
Automated Detection of Malarial Retinopathy in Patients Diagnosed With Cerebral Malaria
Lead Sponsor:
VisionQuest Biomedical LLC
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Kamuzu University of Health Sciences
Conditions:
Cerebral Malaria
Malarial Retinopathy
Eligibility:
All Genders
Up to 21 years
Brief Summary
The focus of the study is performance validation of ASPIRE software device in processing mydriatic retinal images of a patient with clinically diagnosed Cerebral Malaria (CM), to detect malarial retin...
Detailed Description
A prospective, pivotal, multi-center clinical study was conducted at 12 healthcare facilities (hospitals and clinics) across two countries in Africa, Malawi and Nigeria; with the goal to validate the ...
Eligibility Criteria
Inclusion
- 1\. Pediatric patients under 21 years admitted to any one of the study sites who satisfy the standard clinical case definition of cerebral malaria according to the World health organization (WHO) criteria:
- Blantyre coma score of ≤2
- Known positive result of a malaria test for peripheral Plasmodium falciparum parasitemia (blood smear or malaria rapid diagnostic test) 2. Consent provided by parents/caregivers of the eligible pediatric patients
Exclusion
- Pediatric patients admitted who satisfy the standard clinical case definition of cerebral malaria, but there is no clinician/nurse available to do an examination within 6 hours of admission, or no consent provided by parents/caregivers.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2024
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT06915285
Start Date
March 15 2022
End Date
April 30 2024
Last Update
July 3 2025
Active Locations (1)
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1
Mlambe mission hospital
Mlambe, Malawi