Eliminating Gambiense sleeping sickness using a single-dose oral treatment in screened seropositive people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 3 trial combines an epidemiological study to see if zero prevalence can be reached with a screen-and-treat approach using acoziborole, and a nested safety study to gather additional safety data in seropositive individuals. Lead coordination is by ITM with DNDi sponsoring the safety component. The study will screen endemic villages, treat seropositive individuals with a single oral dose of acoziborole without parasitological confirmation, and assess cost-effectiveness, diagnostic tests, and transmission outcomes. The primary aim is to determine if this strategy can interrupt transmission within three years and beyond, while monitoring safety in treated participants. The trial leverages a simplified treatment pathway to potentially improve screening uptake and reduce the need for invasive procedures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants able to give signed informed consent and assent form for adolescents, which includes willingness to comply with the schedule of follow-up visits and other requirements and restrictions listed in the informed consent form (ICF) and in this protocol
* All sexes
* 11 years of age or older at the start of the study and weight ≥30 kg at the screening of Part B
* Participants who are CATT test or HAT RDT positive (information provided by the mobile team and included into TrypElim (see Part A)
* Participants who are able to ingest oral tablets
* Participants with known address and/or contact details provided
* Participants who are able to comply with the schedule of follow-up visits and other requirements of the study
* Participants must agree not take part in any other clinical trials during the participation in part B of this study
* Participants of child-bearing potential must be willing to use appropriate contraceptive methods.

Exclusion Criteria:

* Individuals with a positive parasitological exam on the spot at baseline (mAECT or lymph gland puncture)
* Participants previously treated for g-HAT or previously treated because of gHAT seropositive results
* Pregnant women
* Breast-feeding women
* Children ≥11 years, but under 30kg body weight at the screening for part B
* Clinically significant medical condition that could, in the opinion of the investigator, jeopardise the subject's safety or participation in the study
* Individuals presenting a jaundice at screening
* Participants who are taking, or who are expected to need to start within 3 months, a medicine (including traditional or herbal) which may interact with acoziborole and which cannot be stopped or adjusted (please refer to investigator manual or contact DNDi)

Where it's running

• Coordination Provincial de Lutte contre la THA
  Bwamanda, Democratic Republic of the Congo Recruiting

Study contacts

• Study coordinator: Elena Nicco
• Email: enicco@itg.be
• Phone: +3232476497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.