Objective: Develop and register acoziborole as a single-dose, oral treatment for children with Stage 1 and Stage 2 sleeping sickness caused by T.b.gambiense
Project start: 2020
Drugs for Neglected Diseases initiative (DNDi), DRC and Switzerland
Epicentre, France
Institut National de Recherche Biomédicale (INRB), Democratic Republic of Congo
National HAT Control Programme of the Democratic Republic of Congo
National HAT Control Programme of the Republic of Guinea
The project, known as ACOZI-KIDS, aims to:
- Assess a paediatric indication of acoziborole – a single-dose, oral treatment for Stage 1 and Stage 2 sleeping sickness caused by T.b. gambiense – for children aged between 1 and 14 years old and weighing between 10 and 40 kilograms in the Democratic Republic of Congo and Guinea
- Disseminate the study results to facilitate the treatment of T.b. gambiense sleeping sickness in children
ACOZI-KIDS aims to make treatment of children with sleeping sickness much simpler. Giving an oral single-dose treatment at the point of diagnosis would avoid the need for costly hospitalisation in specialised health centres, painful lumbar punctures, and treatment using injections. As a result, it would be easier for children to complete the treatment and shorten the delay between diagnosis and effective treatment, which could contribute to stopping disease progression and avoid neurological disorders in this population.
The ACOZI-KIDS project brings together a consortium of European and African experts: DNDi, the National Control Programmes for Human African Trypanosomiasis (PNLTHA) of the Democratic Republic of Congo and Guinea, Epicentre, the Research Institute for Development (IRD), and the Nova University of Lisbon/Institute of Hygiene and Tropical Medicine (IHMT/NOVA). Local health care staff will be trained in the management of paediatric patients, which will strengthen the public health system for diagnosing and treating sleeping sickness.
Project update
2023
All nine children treated with 640 mg of acoziborole completed the 12-month follow-up visit. No safety concerns were noted, all children were cured, and no relapses were observed. Pharmacokinetic data collected during the study confirmed the dose adjustment based on body weight is adequate. In 2024, children weighing between 10 kg and 40 kg and aged between 1 and 14 years old will be included in ongoing studies in the Democratic Republic of the Congo and Guinea.
2022
The first child participating in the clinical trial was treated for sleeping sickness on 15 July in Bandundu, in the Democratic Republic of Congo. Nine children aged between 11 and 14 years have been treated so far, each receiving 640 mg of acoziborole. The pharmacokinetic data from these first patients will be analysed to confirm or adapt the dosing regimen for younger patients, aged between 1 and 14.
Funding
This project (grant RIA2019PD) is part of the European and Developing Countries Clinical Trials Partnership Association (EDCTP2) programme supported by the European Union.
Other funding:
UPDATED 18 MAR 2024
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