Clinical trial NCT05466630: Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis
Official title: Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis in Côte d'Ivoire and Guinea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human African Trypanosomiasis
Sleeping Sickness
Trypanosoma Brucei Gambiense; Infection
West African Sleeping Sickness
Keywords: Diagnosis
Lead sponsor: Institut de Recherche pour le Developpement
Sponsor class: OTHER_GOV
Collaborators: name: Foundation for Innovative New Diagnostics
name: Programme National de lutte contre la THA, Guinée
name: Université Jean Lorougnon Guédé, Daloa
name: Institut Pasteur, Guinée
name: Institut Pierre Richet, Guinée
First posted: 2022-07-20
Enrollment: 1095
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea
timeFrame: 1 month
Secondary outcomes:
measure: Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea, in function of malaria status
timeFrame: 1 month
measure: Specificity of immunologic and molecular laboratory tests for diagnosis of HAT in serological suspects
timeFrame: 1 year
Other outcomes:
Locations:
city: Bonon
country: Côte D'Ivoire
facility: Université Jean Lorougnon Guédé de Daloa
city: Dubréka
country: Guinea
facility: Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie
Study officials:
affiliation: Université Jean Lorougnon Guédé de Daloa
name: Martial N'Djetchi Kassi
role: PRINCIPAL_INVESTIGATOR
affiliation: Programme National de lutte contre de la THA en Guinée
name: Oumou Camara
role: PRINCIPAL_INVESTIGATOR
References: