NCT05466630

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,095

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2022

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

July 7, 2022

Last Update Submit

April 4, 2024

Conditions

Human African TrypanosomiasisSleeping SicknessTrypanosoma Brucei Gambiense; InfectionWest African Sleeping Sickness

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 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

    1 month

  • Specificity of immunologic and molecular laboratory tests for diagnosis of HAT in serological suspects

    1 year

Study Arms (1)

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

Diagnostic Test: Serological field test for HATDiagnostic Test: malaria rapid testDiagnostic Test: Immunologic laboratory testsDiagnostic Test: Molecular laboratory tests

Interventions

Serological field test for HATDIAGNOSTIC_TEST

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)
participant
malaria rapid testDIAGNOSTIC_TEST

RDT detecting HRP2 plasmodium antigen.

participant
Immunologic laboratory testsDIAGNOSTIC_TEST

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
participant
Molecular laboratory testsDIAGNOSTIC_TEST

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
participant

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Université Jean Lorougnon Guédé de Daloa

Bonon, Côte d’Ivoire

Location

Programme Nationale de Lutte contre la Trypanosomiase Humaine Africaine, Ministère de Santé, Division Prévention et Lutte contre la Maladie

Dubréka, Guinea

Location

Related Publications (1)

  • 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.

    PMID: 38978124DERIVED

MeSH Terms

Conditions

Trypanosomiasis, AfricanInfectionsDisease

Condition Hierarchy (Ancestors)

TrypanosomiasisEuglenozoa InfectionsProtozoan InfectionsParasitic DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martial N'Djetchi Kassi

    Université Jean Lorougnon Guédé de Daloa

    PRINCIPAL INVESTIGATOR

  • Oumou Camara

    Programme National de lutte contre de la THA en Guinée

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 20, 2022

Study Start

June 20, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Locations

CÔ(1)GU(1)