Status:
UNKNOWN
Evaluating the Clinical Performance and Usability of Novel Malaria RDTs in Brazil
Lead Sponsor:
PATH
Collaborating Sponsors:
Centro de Pesquisa em Medicina Tropical de Rondonia
Conditions:
Malaria
Eligibility:
All Genders
2+ years
Phase:
NA
Brief Summary
Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clini...
Detailed Description
Primary Objectives 1.1 To assess the sensitivity, specificity and, when applicable, positive and negative predicting values (PPV and NPV) \[altogether referred to hereafter as "diagnostic accuracy"\]...
Eligibility Criteria
Inclusion
- Inclusion Criteria (diagnostic accuracy):
- Aged 2 years of age or older
- Presenting at the study site with fever or a history of fever during the preceding 48-hours
- Freely agreeing to participate by providing informed consent (and assent, as applicable)
- Exclusion Criteria (diagnostic accuracy):
- \- Presence of symptoms and signs of severe illness and/or central nervous system infections as defined by WHO guidelines
- Inclusion Criteria (usability):
- Aged 18 years of age or older
- Provides malaria case management at the study site
- Considered an intended user of the index tests (lay user or healthcare worker)
- Freely agreeing to participate by providing informed consent
- Exclusion Criteria (usability):
- None
Exclusion
Key Trial Info
Start Date :
July 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
1030 Patients enrolled
Trial Details
Trial ID
NCT05317117
Start Date
July 4 2022
End Date
December 31 2022
Last Update
September 27 2022
Active Locations (1)
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1
Centro de Pesquisa em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, Rondônia, Brazil, 76812-329