An interventional study of Serological field test for HAT and malaria rapid test in Human African Trypanosomiasis, Sleeping Sickness and Trypanosoma Brucei Gambiense; Infection, sponsored by Institut de Recherche pour le Developpement. Completed at 2 sites in 2 countries. Open to participants aged 10 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Institut de Recherche pour le Developpement · Not applicable, Interventional, and Diagnostic
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.
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.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 1,095 is above the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Institut de Recherche pour le Developpement is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: Serological field test for HAT · Diagnostic Test: malaria rapid test · Diagnostic Test: Immunologic laboratory tests · Diagnostic Test: Molecular laboratory tests
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.
Also known as: 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)
RDT detecting HRP2 plasmodium antigen.
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
Also known as: trypanolysis, ELISA/T.b.gambiense, g-iELISA
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
Also known as: Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCK
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
Time frame: 1 month
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
Time frame: 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.
Time frame: 1 year
Plan to share: 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.
Time frame: Data are estimated to be deposited about 1 year after the start of recruitment. Data will remain available as long as the study is showcased on datasud
Access criteria: Metadata will be public. Personal health data, may be considered "sensitive", will be under controlled access by a data access committee which will assess specific requests for data use.
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Ran from Jun 2022 to primary completion in Aug 2022, 2 months.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Institut de Recherche pour le Developpement