Human African TrypanosomiasisNCT05637632
Assessment of Recombinant HAT-RDT Specificity
An observational study of Human African Trypanosomiasis, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human African Trypanosomiasis
- How many people
- 1,504 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 20 Sep 2022to 20 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population are the people living in villages that are at risk for HAT infection, as the first stade of the disease is asymptomatic or with non-specific symptoms, the whole village is invited to participate in the active screening activity. This is routine active screening done by the mobile team. they study team will recruit people that participate to the screening campaign.
Who may be able to join
- 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
Who cannot join
- Chilrden younger than 12 years old
- previously treated for HAT
- refusal to provide informed consent
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA)
Kinshasa, 0000
About this study
Official title: Assesslebt 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.
Read the detailed 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.
- Conditions
- Human African Trypanosomiasis
- Keywords
- rapid diagnostic test, serologic and molecular diagnosis of HAT, neglected tropical disease
- Medical subject headings
- Neglected Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of recombinant CORIS rapid diagnostic test for HAT
recombinant RDT for detection of HAT developed by CORIS, determine its field performance
Measured: 1 month
Specificity of recombinant BIOLINE rapid diagnostic test for HAT
recombinant RDT for detection of HAT developed by BIOLINE, determine its field performance
Measured: 1 months
Secondary outcomes (2)
iELISA
determine performance of inhibition ELISA test to replace Trypanolyse test
Measured: 3 months
Molecular
determine if active infection of HAT is present using molecular testing technique, determine its performances
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start20 Sep 2022
- Primary completion20 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human African TrypanosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Epco Hasker, Phd PH, Study director, Insitute of Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637632
- Sponsor's protocol ID
- HAT-RDT
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymity of participants must be guaranteed anonymised study results can be shared with other researchers
Publications
Tablado Alonso S, Inocencio Da Luz R, Van Reet N, Ngay I, Pemba MM, Roge S, Kwete J, Nicco E, Rigouts L, Miaka EM, Ngoyi DM, Verle P, Buscher P, Hasker E. Prospective evaluation of 2nd generation rapid diagnostic tests for the serological diagnosis of gambiense human African trypanosomiasis in the Democratic Republic of the Congo. BMC Infect Dis. 2025 Dec 6;26(1):46. doi: 10.1186/s12879-025-12278-3.
PubMed 41351066
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesslebt of Recombinant HAT-RDT Specificity
- ClinicalTrials.gov ID
- NCT05637632
- Acronym / sponsor ID
- HAT-RDT
- Conditions
- Human African Trypanosomiasis
- Keywords
- rapid diagnostic test, serologic and molecular diagnosis of HAT, neglected tropical disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 20 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are the people living in villages that are at risk for HAT infection, as the first stade of the disease is asymptomatic or with non-specific symptoms, the whole village is invited to participate in the active screening activity. This is routine active screening done by the mobile team. they study team will recruit people that participate to the screening campaign.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Chilrden younger than 12 years old
- previously treated for HAT
- refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
2 secondary outcomes
iELISA
Time frame: 3 months
Molecular
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 41351066Tablado Alonso S, Inocencio Da Luz R, Van Reet N, Ngay I, Pemba MM, Roge S, Kwete J, Nicco E, Rigouts L, Miaka EM, Ngoyi DM, Verle P, Buscher P, Hasker E. Prospective evaluation of 2nd generation rapid diagnostic tests for the serological diagnosis of gambiense human African trypanosomiasis in the Democratic Republic of the Congo. BMC Infect Dis. 2025 Dec 6;26(1):46. doi: 10.1186/s12879-025-12278-3.
- Individual participant dataSharing planned: Undecided. anonymity of participants must be guaranteed anonymised study results can be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Epco Hasker, Phd PH study director
Insitute of Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human African Trypanosomiasis, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of recombinant CORIS rapid diagnostic test for HAT (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05637632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.