Pharmacokinetic, efficacy, safety, and tolerability study of a single dose of acoziborole under fasting conditions in paediatric patients from 1 to 14 years of age and with human African trypanosomiasis due to T.b. gambiense
Study design
Open-label, non-randomised, single arm, multicentre, phase II/III study,
Our role
Statistics and Data Management
Partners
- Drugs for Neglected Diseases initiative (DNDi)
- Institut de Recherche pour le Développement (IRD), France
- Institut National de Recherche Biomédicale (INRB), Democratic Republic of Congo
- Institute of Hygiene and Tropical Medicine (IHMT/NOVA), Nova University Lisbon, Portugal
- National HAT Control Programme of the Democratic Republic of Congo
- National HAT Control Programme of the Republic of Guinea
- Epicentre
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
- Federal ministry of research, ttechnology and space, Germany
- Gates Foundation
- Nationale postcode loterij
- Norvège
- Uk international develpment
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
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
Expected impact
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 hospitalization in specialized 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.
