Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis (SpeSerTryp)

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.

Study Overview

• Status: Completed
• Conditions: Sleeping Sickness; Human African Trypanosomiasis; Trypanosoma Brucei Gambiense; Infection; West African Sleeping Sickness
• Intervention / Treatment: Diagnostic test: Serological field test for HAT; Diagnostic test: malaria rapid test; Diagnostic test: Immunologic laboratory tests; Diagnostic test: Molecular laboratory tests

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 Type: Interventional
• Enrollment (Actual): 1095
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veerle Lejon; Phone Number: +33467593950; Email: veerle.lejon@ird.fr
• Study Contact Backup: Name: Sylvain Bieler; Phone Number: +41 22 710 27 81; Email: sylvain.bieler@finddx.org

Study Locations

• Côte D'Ivoire
  • Bonon, Côte D'Ivoire
    • Université Jean Lorougnon Guédé de Daloa
• Guinea
  • Dubréka, Guinea
    • Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• severe anemia hindering blood sampling
• severe illness hindering obtention of informed consent (eg coma, cognitive deficiency etc)
• history of sleeping sickness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: participant; 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; 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.; Other Names: 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); Diagnostic test: malaria rapid test; RDT detecting HRP2 plasmodium antigen.; Diagnostic test: Immunologic laboratory tests; 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; Other Names: trypanolysis, ELISA/T.b.gambiense, g-iELISA; Diagnostic test: Molecular laboratory tests; 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; Other Names: Trypanozoon RT-qPCR multiplex, SNP RT-qPCR, SHERLOCK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	1 year

Collaborators and Investigators

• Sponsor: Institut de Recherche pour le Developpement
• 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
• Investigators: Principal Investigator: Martial N'Djetchi Kassi, Université Jean Lorougnon Guédé de Daloa; Principal Investigator: Oumou Camara, Programme National de lutte contre de la THA en Guinée

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diagnosis
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Euglenozoa Infections; Trypanosomiasis; Trypanosomiasis, African
• Other Study ID Numbers: SpeSerTryp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No