Assessment of Recombinant HAT-RDT Specificity

Human African Trypanosomiasis Clinical Trial

Official title:

Assesslebt of Recombinant HAT-RDT Specificity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05637632
• Other study ID #: HAT-RDT
• Status: Completed
• Start date: September 20, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: September 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1504
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Human African Trypanosomiasis
• Trypanosomiasis
• Trypanosomiasis, African

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)	Kinshasa

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specificity of recombinant CORIS rapid diagnostic test for HAT	recombinant RDT for detection of HAT developed by CORIS, determine its field performance	1 month
Primary	Specificity of recombinant BIOLINE rapid diagnostic test for HAT	recombinant RDT for detection of HAT developed by BIOLINE, determine its field performance	1 months
Secondary	iELISA	determine performance of inhibition ELISA test to replace Trypanolyse test	3 months
Secondary	Molecular	determine if active infection of HAT is present using molecular testing technique, determine its performances	4 months