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RECRUITING
NCT07789743
PHASE3

Stop Transmission of Gambiense Human African Trypanosomiasis

Sponsor: Institute of Tropical Medicine, Belgium

View on ClinicalTrials.gov

Summary

This protocol describes both the epidemiological study which aims at assessing whether over a three-year period a zero prevalence can be achieved when implementing a screen \& treat approach with acoziborole, as well as a nested clinical study aimed at generating further evidence on safety of acoziborole in gambiense human African trypanosomiasis (gHAT) seropositives individuals. The overall coordinator will be ITM. ITM will be fully responsible for the epidemiological study (study Part A), including cost effectiveness and evaluation of diagnostic tests. DNDi will be the legal sponsor of the nested safety clinical study (study Part B) and will ensure compliance with regulatory requirements and good clinical practices (GCP) for this part of the study. We hypothesize that by systematically screening the populations of all endemic villages in a well-defined HAT focus and by expanding gHAT treatment to all seropositives, we will be able to arrive at a zero prevalence over a three-year period. The objectives are to evaluate whether a strategy based on widened treatment for all parasitologically negative seropositive gHAT suspects with acoziborole can lead to interruption of transmission of T.b.gambiense in a mainland focus and to assess the safety of acoziborole in gHAT seropositve individuals and parasitologically negative.

Official title: An Intervention Study to Evaluate the Impact of Treating gHAT Seropositives Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositives Individuals.

Key Details

Gender

All

Age Range

11 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2500

Start Date

2024-03-15

Completion Date

2027-12-30

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

Acoziborole

treatment of seropositive individuals (positive serology test, but parasitology not confirmed). Subjects agreeing to participate study and matching the inclusion/exclusion criteria will receive acoziborole 960 or 640 mg in a single intake at study day 1. Following treatment, participants will attend follow-up visits at home or at the study centre at 3 days and 3-months post-treatment.

Locations (1)

Coordination Provincial de Lutte contre la THA

Bwamanda, Democratic Republic of the Congo