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One pill may halt sleeping sickness spread

NCT ID NCT07789743

Disease control Sponsor: Institute of Tropical Medicine, Belgium Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether giving a single dose of acoziborole to people who test positive for sleeping sickness antibodies, but show no active infection, can stop the disease from spreading in a community. Researchers will screen entire villages and treat all seropositive individuals, then track whether new cases drop to zero over three years. The study also monitors the drug's safety in this group. Participants are 11 years or older and weigh at least 30 kg.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acoziborole
What this could lead to
If successful, this could help eliminate sleeping sickness in affected regions by stopping the parasite from spreading.
What could go wrong
The trial is large and long, and results depend on real-world screening. Safety data is still being gathered, and the drug may not fully interrupt transmission.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

11 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

infection by Trypanosoma gambiense trypanosomiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trypanosomiasis; african, due to trypanosoma brucei gambiense, gambiense

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Coordination Provincial de Lutte contre la THA

    RECRUITING

    Bwamanda, Democratic Republic of the Congo