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Completed

NCT Number: NCT05637632

Assessment of Recombinant HAT-RDT Specificity

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.

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Key information

Conditions

Human African Trypanosomiasis Disease Attributes Neglected Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)

Kinshasa, 0000, Democratic Republic of the Congo

About this study

This prospective study will follow two different mobile units as they go on their routine screening of the gHAT endemic population. Study participants will be enrolled during the routine screening, and after providing informed consent, they will be asked for a 4.5 ml venous blood sample. The three RDTs (HAT Sero-K-SeT, rHAT Sero-K-SeT, Bioline HAT 2.0) and CATT will be performed on site, while part of the sample will be mixed with DNA/RNA Shield for molecular analysis and the rest will be left to decant, to collect plasma for iELISA and TL. Confirmatory tests will be performed in the field on any seropositive individual. Should any case be confirmed, treatment will be offered, free of charge, following PNLTHA guidelines.

The obtained data will allow for a very precise estimation of the specificity of the newly developed recombinant RDTs. This study does not aim to determine the sensitivity of these tests since, due to the very low prevalence, the chance of having sufficient seropositive samples and/or finding a true case are very slim. The diagnostic performance of iELISA and novel molecular tests will also be determined.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 old

Exclusion criteria

  • Chilrden younger than 12 years old
  • previously treated for HAT
  • refusal to provide informed consent

Treatment and study plan

Primary outcomes

  1. Specificity of recombinant CORIS rapid diagnostic test for HAT

    Time frame: 1 month

    recombinant RDT for detection of HAT developed by CORIS, determine its field performance

  2. Specificity of recombinant BIOLINE rapid diagnostic test for HAT

    Time frame: 1 months

    recombinant RDT for detection of HAT developed by BIOLINE, determine its field performance

Secondary outcomes

  1. iELISA

    Time frame: 3 months

    determine performance of inhibition ELISA test to replace Trypanolyse test

  2. Molecular

    Time frame: 4 months

    determine if active infection of HAT is present using molecular testing technique, determine its performances

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Registry information

Official study title

Assesslebt of Recombinant HAT-RDT Specificity

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 5, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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