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Stop Transmission of Gambiense Human African Trypanosomiasis (STROgHAT)
Sponsor: Drugs for Neglected Diseases
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. The investigators 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, that it 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 Seropositive Subjects With Acoziborole on Transmission of T.b. Gambiense, and Obtain Further Safety Data on Acoziborole in gHAT Seropositive Individuals
Key Details
Gender
All
Age Range
11 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2500
Start Date
2024-04-08
Completion Date
2027-12-30
Last Updated
2024-04-10
Healthy Volunteers
No
Conditions
Interventions
Treatment of seropositive individuals (positive serology test, but parasitology not confirmed)
Subjects agreeing to participate in the 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.