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NCT05637632
Assessment of Recombinant HAT-RDT Specificity
Conditions: Human African Trypanosomiasis
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: 1
Enrollment: 3000
Sponsor: Institute of Tropical Medicine, Belgium
Location: Congo, The Democratic Republic of the
Summary
Human African trypanosomiasis HAT, or sleeping sickness, is a tropical disease caused mainly by the parasite Trypanosoma brucei gambiense (gHAT).
After a severe epidemic in the 1990s, the World Health Organization (WHO) now targets elimination of transmission of gHAT by the year 2030, which heavily relies on its diagnosis and treatment.
Traditional screening tests (like CATT or rapid diagnostic tests (RDTs)) are based on the detection of antibodies against the parasite using native antigens, which are costly and dangerous to produce.
New serological tests, using recombinant antigens, have been developed, but little is known about their field performance.
The primary objective of this study is to assess the specificity of the newly-developed recombinant RDTs, since it will become very relevant as we move forward towards a screen&treat strategy.
We will also compare the diagnostic accuracy and overall performance of iELISA and molecular testing.
Eligibility Criteria
Inclusion Criteria:Willing and able to provide written informed consent (and assent for minors 12-17years old)Be enrolled in routine HAT screening activities dony by the mobile unit (PNLTHA mobile unit routine active screening teams that visit villages at risk for HAT).
People living in the village are targeted for screening.Participants must be at least 12 years oldExclusion Criteria:Chilrden younger than 12 years oldpreviously treated for HATrefusal to provide informed consent
Source: ClinicalTrials.gov (NCT05637632). StuddyBuddy aggregates publicly available trial information.