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One pill could change the fight against sleeping sickness in kids

NCT ID NCT05433350

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single dose of the oral drug acoziborole in 35 children aged 1 to 14 with sleeping sickness (g-HAT). The goal was to see how the drug works in the body and if it is safe and effective. This simpler treatment could help control the disease in remote areas where access to care is limited.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

35 people

The number who actually took part.

Started

Jul 2022

Finished

Mar 2026

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

1 year to 14 years

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: * Signed informed consent from one parent or from the legal representative * Assent from the paediatric patient (for paediatric patients \>6 years of age) to participate in the study, collected in the presence of an impartial witness * Between 1 and 14 years of age and between 10 and ≤40 kg (as per the requirements of step 1 and step 2) * Male or female * Evidence of trypanosomes in any body fluid (blood or lymph or CSF) * Having a permanent address and able to comply with the schedule of follow-up visits * Agreement to not take part in any other clinical trials during the participation in this study * For pubescent girls of childbearing potential must agree to have avoid getting pregnant during the screening period and up to 3 months after acoziborole dosing by using an acceptable effective contraception method (sexual abstinence, condom, injectable progestin-only contraceptive) * Agreement not to continue any treatment (including traditional/herbal medicine) without consulting the investigator * Agreement not to start a treatment (including traditional/herbal medicine) during 4 months after intake of acoziborole without consulting the Investigator Exclusion Criteria: * Previous treatment for g-HAT * Refusal to participate in the study, expressed by the paediatric patient and/or parent or legal representative * Complicated severe acute malnutrition as defined by weight for height (-3 SDs Z score) * Unable to take medication by the oral route * Clinically significant medical condition (other than HAT) that could, in the opinion of the Investigator, jeopardise the patient's safety or interfere with participation in the study * Any condition (excluding HAT-specific symptoms) that affects the patient's and/or parent's ability to communicate with the Investigator as required to complete the study * Prior enrolment in the study or prior intake of acoziborole * Foreseeable difficulty complying with follow-up, including family of migrant workers, refugee status, itinerant trader, etc. * Clinically significant laboratory test abnormality, with: * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than twice the upper limit of normal (ULN) * Total bilirubin more than 1.5 x ULN * Severe leukopenia at \<2000/mm3 * Potassium \<3.5 mmol/L * Any other clinically significant laboratory test abnormality * Pregnancy confirmed by a positive urine pregnancy test (during the screening period and/or within 24 hours prior to the start of treatment) for pubescent girls of childbearing potential * Not tested for malaria and/or not having received appropriate treatment for malaria * Not having received appropriate treatment for soil-transmitted helminthiasis * Paediatric patient who is taking praziquantel, erythromycin, ritonavir, lopinavir, or darunavir and could not stop this treatment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CDTC Katanda

    Katanda, East Kasai, Democratic Republic of the Congo

  • General Hospital of Bandundu

    Bandundu Province, Bandundu, Democratic Republic of the Congo

  • General Referral Hospital of Dubreka

    Dubréka, Guinea

  • HGR Bagata

    Bagata, Kwilu, Democratic Republic of the Congo

  • Hospital of Masi-Manimba

    Masi-Manimba, Kwilu, Democratic Republic of the Congo

  • Hôpital Général de Dipumba

    Mbuji-Mayi, East Kasai, Democratic Republic of the Congo

More trials for these conditions

Other studies related to the condition(s) this trial covers.