Prospective Evaluation of the Specificity of Serological Tests for Human African Trypanosomiasis

Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea

Secondary Outcome

 Specificity of serological field test for diagnosis of HAT during active screening in Côte d'Ivoire and Guinea, in function of malaria status

Condition

Human African Trypanosomiasis

Intervention

Serological field test for HAT

Study Arms / Comparison Groups

 participant
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

1000

Start Date

June 20, 2022

Completion Date

April 30, 2023

Primary Completion Date

August 31, 2022

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
      

Gender

All

Ages

10 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Martial N'Djetchi Kassi, +33467593950, [email protected]

Location Countries

Côte D'Ivoire

Location Countries

Côte D'Ivoire

Administrative Informations


NCT ID

NCT05466630

Organization ID

SpeSerTryp


Responsible Party

Principal Investigator

Study Sponsor

Institut de Recherche pour le Developpement

Collaborators

 Foundation for Innovative New Diagnostics

Study Sponsor

Martial N'Djetchi Kassi, Principal Investigator, Université Jean Lorougnon Guédé de Daloa


Verification Date

July 2022