Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05466630 |
| Other study ID # |
SpeSerTryp |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 20, 2022 |
| Est. completion date |
August 31, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Institut de Recherche pour le Developpement |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
