Stop Transmission of Gambiense Human African Trypanosomiasis

NCT07789743 | Recruiting Phase 3 DMC

• 1 other identifier: STROgHAT
• Study Type: interventional
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Trypanosomiasis; African, Due to Trypanosoma Brucei Gambiense, Gambiense

Keywords

acoziborole, elimination of transmission, seropositive

Outcome Measures

Primary Outcomes (2)

• interruption of transmission of T.b. gambiense

  \- 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. The number of parasitologically negative seropositive gHAT suspects is reduced to zero or near zero within the timeframe of the project

  4 years

• Assessment of Safety

  To assess the safety of acoziborole in gHAT seropositive individuals and parasitologically-negative by measuring the proportion of participants who present related treatment emergent severe adverse events. Mild, moderate and severe related ermergent adverse events will be measured.

  3 year

Other Outcomes (2)

• economic evaluation

  4 years

• assessment of the performance of several diagnostic tests

  4 years

Study Arms (1)

treatment of seropositives

EXPERIMENTAL

The investigational product (IP) is: * acoziborole three 320-mg tablets (960 mg dose), administered by the oral route to adolescent and adults ≥15 years as single dosing regimen on Day 1 of the study in fed or fasting state * acoziborole two 320-mg tablets (640 mg dose), administered by the oral route to children 11-14 years (and ≥30kg) as single dosing regimen on Day 1 of the study in fed or fasting state No active comparative treatment will be used in this study Doses and treatment regimens * Adolescent and adults ≥15 years: 960 mg (3x320mg) oral unique dose in fed or fasting state * Children 11-14 years (and ≥30kg): 640 mg (2x320mg) oral unique dose in fed or fasting state

Drug: Acoziborole

Interventions

Acoziborole DRUG

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.

treatment of seropositives

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Drugs for Neglected Diseases: collaborator
• Institut de Recherche pour le Developpement: collaborator
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Ministry of Public Health, Democratic Republic of the Congo: collaborator

Study Sites (1)

Coordination Provincial de Lutte contre la THA

Bwamanda, Democratic Republic of the Congo

RECRUITING

MeSH Terms

Conditions

Trypanosomiasis

Condition Hierarchy (Ancestors)

Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections

Study Officials

• Elena Nicco

  Insitute of Tropical Medicine

  STUDY DIRECTOR

Central Study Contacts

Elena Nicco

CONTACT

+3232476497; enicco@itg.be

Digas Ngolo, MD MPH

CONTACT

+243813180161; dngolo@dndi.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: one-arm, open label, non-randomized, multicentre, phase IIIb study

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 27, 2026
• Study Start: March 15, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)