Human African TrypanosomiasisSpeSerTrypNCT05466630
Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis
A study testing Serological field test for HAT, malaria rapid test and Immunologic laboratory tests in people with Human African Trypanosomiasis and Sleeping Sickness, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.
Trial summary
This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection
- What is being tested?
- Serological field test for HAT, malaria rapid test and Immunologic laboratory tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,095 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Jun 2022to 31 Aug 2023
- Phase
- Interventional
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- at least 10 years old
- signed the informed consent form (in case of minor: parent or tutor signs informed consent form and minor signs ascent form)
Who cannot join
- severe anemia hindering blood sampling
- severe illness hindering obtention of informed consent (eg coma, cognitive deficiency etc)
- history of sleeping sickness
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Guinea1 site
Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie
Dubréka
About this study
Official title: Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis in Côte d'Ivoire and Guinea
This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.
Read the detailed description
In the last decade, the prevalence of Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) has fallen and HAT has been targeted for transmission interruption by 2030. To achieve this goal, disease surveillance remains essential and is based on the identification of cases after screening carried out in the field with a serological test.
The SpeSerTryp study is a prospective evaluation of the specificity of serological field tests for the diagnosis of HAT in Côte d'Ivoire and Guinea. Since the prevalence of HAT is low in these countries, sensitivity will not be assessed.
The main objective is to evaluate and compare the specificity of 5 serological field tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT \& HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium ), TDR DCN (USA), and the CATT/T.b. gambiense (Institute of Tropical Medicine Antwerp, Belgium). The secondary objectives are: 1° to assess the specificity of the 5 serological field tests according to malaria status; and 2° to compare the performance of immunological laboratory tests (trypanolysis, ELISA/T.b.gambiense, g-iELISA) and molecular laboratory tests (Trypanozoon RT-qPCR multiplex, SNP RT-qPCR and SHERLOCK) as reference tests to differentiate false positive subjects to serological field tests from subjects who had contact with Tbg. Specificity values will be determined against a composite reference test consisting of the most sensitive HAT parasitological methods. SpeSerTryp is a prospective study that will take place in the endemic health districts of Bonon and Sinfra in Côte d'Ivoire and in the endemic health districts of Forécariah, Dubréka and Boffa in Guinea. In each country, 500 participants will be actively recruited by mobile teams. The inclusion criteria are: Age greater than or equal to 10 years and obtaining signed informed consent. The exclusion criteria are: Severe anemia preventing blood sampling; serious illness preventing the obtaining of informed consent and participation in the study; or history of HAT. After obtaining informed consent, a venous blood sample will be taken (6 mL). This specimen will be used to carry out the 5 serological tests for HAT, the RDT for malaria, and for participants with at least one of the 5 serological tests positive, parasitological confirmation of HAT and molecular and immunological laboratory tests . The duration of participant recruitment is estimated to be around 30 days, while laboratory analyses will take about 6 months. HAT cases identified during the study will be treated in accordance with current national guidelines.
This study will be conducted in accordance with the protocol, the current version of the Declaration of Helsinki, ICH-BPC E6/R2 guidelines, and all national legal and regulatory requirements.
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness
- Being tested
- Serological field test for HAT, malaria rapid test, Immunologic laboratory tests, Molecular laboratory tests
- Keywords
- Diagnosis
- Medical subject headings
- Trypanosomiasis, African, Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serological field test for HATDiagnostic test
Also called Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium)
Whole blood is tested by lateral flow or agglutination (CATT) for the presence of trypanosome specific antibody. Participants testing positive for at least one of these tests will undergo microscopic examination to detect trypanosomes (lymph, mAECT on blood) and DBS will be prepared for immunological and molecular laboratory testing.
malaria rapid testDiagnostic test
RDT detecting HRP2 plasmodium antigen.
Immunologic laboratory testsDiagnostic test
Also called trypanolysis, ELISA/T.b.gambiense, g-iELISA
Laboratory tests detecting trypanosoma brucei gambiense specific (VSG) antibodies in DBS. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests
Molecular laboratory testsDiagnostic test
Also called Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCK
Laboratory tests detecting Trypanozoon specific nucleic acids. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests
| Study group | Role | What they receive |
|---|---|---|
| participant | Other | All eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests Receives: Diagnostic Test: Serological field test for HAT; Diagnostic Test: malaria rapid test; Diagnostic Test: Immunologic laboratory tests; Diagnostic Test: Molecular laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea
Index tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium). Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination
Measured: 1 month
Secondary outcomes (2)
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea, in function of malaria status
Index tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium). Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination. The malaria status will be determined using an RDT detecting HRP2
Measured: 1 month
Specificity of immunologic and molecular laboratory tests for diagnosis of HAT in serological suspects
Index tests: trypanolysis, ELISA/T.b.gambiense, g-iELISA, Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCK. Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start20 Jun 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Foundation for Innovative New Diagnostics, Programme National de lutte contre la THA, Guinée, Université Jean Lorougnon Guédé, Daloa, Institut Pasteur, Guinée, Institut Pierre Richet, Guinée
- Responsible party
- Principal investigator, Veerle Lejon, Institut de Recherche pour le Developpement
- Investigators
- Martial N'Djetchi Kassi, Principal investigator, Université Jean Lorougnon Guédé de DaloaOumou Camara, Principal investigator, Programme National de lutte contre de la THA en Guinée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466630
- Sponsor's protocol ID
- SpeSerTryp
- Acronym
- SpeSerTryp
- Status last verified
- Apr 2024
- First submitted
- 7 Jul 2022
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the open data policy (FAIR data), the final database of the study will be deposited in the IRD's institutional depository "DataSud" and will be identified by a DOI. Metadata describing the database will be under open access. The database itself, containing personal health data, may be considered "sensitive", and will be under controlled access by a data access committee which will assess specific requests for data use. The partners who generated the data will remain the owners of the data.
Publications
N'Djetchi MK, Camara O, Koffi M, Camara M, Kaba D, Kabore J, Tall A, Rotureau B, Glover L, Traore MB, Kone M, Coulibaly B, Adingra GP, Soumah A, Gassama M, Camara AD, Compaore CFA, Camara A, Boiro S, Anton EP, Bessell P, Van Reet N, Bucheton B, Jamonneau V, Bart JM, Solano P, Bieler S, Lejon V. Specificity of serological screening tests and reference laboratory tests to diagnose gambiense human African trypanosomiasis: a prospective clinical performance study. Infect Dis Poverty. 2024 Jul 8;13(1):53. doi: 10.1186/s40249-024-01220-5.
PubMed 38978124
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis in Côte d'Ivoire and Guinea
- ClinicalTrials.gov ID
- NCT05466630
- Acronym / sponsor ID
- SpeSerTryp / SpeSerTryp
- Conditions
- Human African Trypanosomiasis, Sleeping Sickness, Trypanosoma Brucei Gambiense; Infection, West African Sleeping Sickness
- Keywords
- Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,095 participants (actual)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Foundation for Innovative New Diagnostics, Programme National de lutte contre la THA, Guinée, Université Jean Lorougnon Guédé, Daloa, Institut Pasteur, Guinée, Institut Pierre Richet, Guinée
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 20 Jul 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.
This study evaluates and compares the diagnostic specificity of 5 serological field tests for screening of the population at risk for human African trypanosomiasis due to Trypanosoma brucei gambiense.
Detailed description
In the last decade, the prevalence of Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) has fallen and HAT has been targeted for transmission interruption by 2030. To achieve this goal, disease surveillance remains essential and is based on the identification of cases after screening carried out in the field with a serological test.
The SpeSerTryp study is a prospective evaluation of the specificity of serological field tests for the diagnosis of HAT in Côte d'Ivoire and Guinea. Since the prevalence of HAT is low in these countries, sensitivity will not be assessed.
The main objective is to evaluate and compare the specificity of 5 serological field tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT \& HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium ), TDR DCN (USA), and the CATT/T.b. gambiense (Institute of Tropical Medicine Antwerp, Belgium). The secondary objectives are: 1° to assess the specificity of the 5 serological field tests according to malaria status; and 2° to compare the performance of immunological laboratory tests (trypanolysis, ELISA/T.b.gambiense, g-iELISA) and molecular laboratory tests (Trypanozoon RT-qPCR multiplex, SNP RT-qPCR and SHERLOCK) as reference tests to differentiate false positive subjects to serological field tests from subjects who had contact with Tbg. Specificity values will be determined against a composite reference test consisting of the most sensitive HAT parasitological methods. SpeSerTryp is a prospective study that will take place in the endemic health districts of Bonon and Sinfra in Côte d'Ivoire and in the endemic health districts of Forécariah, Dubréka and Boffa in Guinea. In each country, 500 participants will be actively recruited by mobile teams. The inclusion criteria are: Age greater than or equal to 10 years and obtaining signed informed consent. The exclusion criteria are: Severe anemia preventing blood sampling; serious illness preventing the obtaining of informed consent and participation in the study; or history of HAT. After obtaining informed consent, a venous blood sample will be taken (6 mL). This specimen will be used to carry out the 5 serological tests for HAT, the RDT for malaria, and for participants with at least one of the 5 serological tests positive, parasitological confirmation of HAT and molecular and immunological laboratory tests . The duration of participant recruitment is estimated to be around 30 days, while laboratory analyses will take about 6 months. HAT cases identified during the study will be treated in accordance with current national guidelines.
This study will be conducted in accordance with the protocol, the current version of the Declaration of Helsinki, ICH-BPC E6/R2 guidelines, and all national legal and regulatory requirements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| participant | Other | Diagnostic Test: Serological field test for HAT, Diagnostic Test: malaria rapid test, Diagnostic Test: Immunologic laboratory tests, Diagnostic Test: Molecular laboratory testsAll eligible participants will undergo 5 serological field tests for HAT and a malaria test. Those testing positive in at least 1 serological field test will undergo parasitology to confirm HAT and immunological and molecular laboratory tests |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- at least 10 years old
- signed the informed consent form (in case of minor: parent or tutor signs informed consent form and minor signs ascent form)
Key exclusion criteria (3 listed)
- severe anemia hindering blood sampling
- severe illness hindering obtention of informed consent (eg coma, cognitive deficiency etc)
- history of sleeping sickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serological field test for HATAlso: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium)Whole blood is tested by lateral flow or agglutination (CATT) for the presence of trypanosome specific antibody. Participants testing positive for at least one of these tests will undergo microscopic examination to detect trypanosomes (lymph, mAECT on blood) and DBS will be prepared for immunological and molecular laboratory testing. | Diagnostic test | participant |
| malaria rapid testRDT detecting HRP2 plasmodium antigen. | Diagnostic test | participant |
| Immunologic laboratory testsAlso: trypanolysis, ELISA/T.b.gambiense, g-iELISALaboratory tests detecting trypanosoma brucei gambiense specific (VSG) antibodies in DBS. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests | Diagnostic test | participant |
| Molecular laboratory testsAlso: Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCKLaboratory tests detecting Trypanozoon specific nucleic acids. These tests will only be carried out on participants that are positive in at least on of the rapid serological tests | Diagnostic test | participant |
Primary outcome
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea
Time frame: 1 month
Index tests: Bioline HAT 2.0 (Abbott, South Korea), HAT Sero-K-SeT (Coris BioConcept, Belgium), HAT 2.0 Sero-K-SeT (Coris BioConcept, Belgium), RDT DCN (USA), CATT/Tb gambiense (ITM Antwerp, Belgium). Reference test: parasitological confirmation by combined lymph and blood (mAECT) examination
2 secondary outcomes
Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea, in function of malaria status
Time frame: 1 month
Specificity of immunologic and molecular laboratory tests for diagnosis of HAT in serological suspects
Time frame: 1 year
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 5 Apr 2024.
- Derived from this study: PubMed 38978124N'Djetchi MK, Camara O, Koffi M, Camara M, Kaba D, Kabore J, Tall A, Rotureau B, Glover L, Traore MB, Kone M, Coulibaly B, Adingra GP, Soumah A, Gassama M, Camara AD, Compaore CFA, Camara A, Boiro S, Anton EP, Bessell P, Van Reet N, Bucheton B, Jamonneau V, Bart JM, Solano P, Bieler S, Lejon V. Specificity of serological screening tests and reference laboratory tests to diagnose gambiense human African trypanosomiasis: a prospective clinical performance study. Infect Dis Poverty. 2024 Jul 8;13(1):53. doi: 10.1186/s40249-024-01220-5.
- Individual participant dataSharing planned: Yes. As part of the open data policy (FAIR data), the final database of the study will be deposited in the IRD's institutional depository "DataSud" and will be identified by a DOI. Metadata describing the database will be under open access. The database itself, containing personal health data, may be considered "sensitive", and will be under controlled access by a data access committee which will assess specific requests for data use. The partners who generated the data will remain the owners of the data.
Related trials for Human African Trypanosomiasis
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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.
Martial N'Djetchi Kassi principal investigator
Université Jean Lorougnon Guédé de Daloa
Oumou Camara principal investigator
Programme National de lutte contre de la THA en Guinée
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serological field test for HAT, malaria rapid test and Immunologic laboratory tests in people with Human African Trypanosomiasis and Sleeping Sickness, run by Institut de Recherche pour le Developpement at 2 sites in 2 countries.
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 2 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire, Guinea. 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 serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea (time frame: 1 month). 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 NCT05466630, 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 5 Apr 2024.