Status:
COMPLETED
Performance Evaluation of Malaria Plus Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Infections in Patients With Symptoms Suggestive of Malaria
Lead Sponsor:
Abbott Rapid Dx
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Malaria
Eligibility:
All Genders
5+ years
Phase:
NA
Brief Summary
This trial is part of a portfolio of studies designed to assess the clinical and operational performance of Abbott's NxTekTM Malaria Pf Plus and NxTekTM Malaria Pf/Pv Plus Rapid Test Devices.
Detailed Description
A prospective cross-sectional multi-center diagnostic accuracy trial in intended-use settings of the: 1. NxTekTM Malaria Pf/Pv Plus Rapid Test Device for the qualitative detection histidine-rich prot...
Eligibility Criteria
Inclusion
- Aged 5years old or older
- Presenting at the trial site with fever or a history of fever (axillary temp ≥ 37.5C) during the preceding 48hours
- Freely agreeing to participate by providing informed consent (and assent, if applicable)
Exclusion
- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines.
Key Trial Info
Start Date :
May 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2022
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT05286359
Start Date
May 24 2022
End Date
November 17 2022
Last Update
April 24 2023
Active Locations (1)
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1
Medical Parasitology Research Unit, Aklilu Lemma Institute of Pathobiology (ALIPB), Addis Ababa University (AAU).
Addis Ababa, Ethiopia