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Assessment of Recombinant HAT-RDT Specificity

NCT05637632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1504

Last updated 2023-09-28

No results posted yet for this study

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.

Conditions

  • Human African Trypanosomiasis

Sponsors & Collaborators

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Epco Hasker, Phd PH · Insitute of Tropical Medicine

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-02-20
Completion
2023-02-20

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05637632 on ClinicalTrials.gov