• DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
      • Media workshops
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
  • DNDi_Logo_No-Tagline_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • Pandemic preparedness
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies and IP
      • Children’s health
      • Gender equity
      • Climate change
      • AI and new technologies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • Dengue Alliance
      • HAT Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia
      • DNDi South-East Asia
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
      • Podcasts, radio & TV
      • Media workshops
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
      • Our prizes and awards
      • Our story: 20 years of DNDi
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > Scientific articles
Sep 2022

Safety and efficacy of oral fexinidazole in children with gambiense human African trypanosomiasis: a multicentre, single-arm, open-label, phase 2/3 trial

The Lancet Global Health

by Kande Betu Kumesu V, Mutombo Kalonji W, Bardonneau C, Valverde Mordt O, Tete D, Blesson S, Simon F, Delhomme S, Bernhard S, Nganzobo Ngima P, Mahenzi Mbembo H,  Fina Lubaki JP, Lumeya Vuvu S, Kuziena Mindele W, Ilunga Wa Kyhi M, Mandula Mokenge G, Kaninda Badibabi L, Kasongo Bonama A, Kavunga Lukula P, Lumbala C, Scherrer B, Strub-Wourgaft N, Tarral A. The Lancet Global Health 2022, 10(11): e1665-1674. doi: 10.1016/S2214-109X(22)00338-2

Summary: This single-arm, open-label, phase 2/3 trial assessed the safety and efficacy of fexinidazole in children with sleeping sickness caused by Trypanosoma brucei gambiense (g-HAT). This plug-in to the pivotal trial was conducted in the Democratic Republic of the Congo in 125 children with any stage of g-HAT (69 with stage 1, 19 with early stage 2, and 37 with late stage 2). The treatment success rate at 12 months was 97.6%, exceeding the targeted value of 92% (98.6% for stage 1, 94.7% for early stage 2, and 97.3% for late stage 2). No new safety issues were observed and the authors conclude that fexinidazole is a safe and effective first-line treatment option for all stages of g-HAT in paediatric patients.

access the article
Children Clinical trials Sleeping sickness Africa

Latest scientific articles

Loading...
Scientific articles
30 Sep 2025

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

BMJ Open
Scientific articles
29 Sep 2025

Performance evaluation of rapid diagnostic tests for Chagas disease in Jutiapa, Guatemala

Journal of the Brazilian Society of Tropical Medicine
Scientific articles
22 Sep 2025

Mass balance, pharmacokinetics, metabolism, and excretion of radiolabeled acoziborole, a potential novel treatment for human African trypanosomiasis, following single microtracer oral dose to humans

Antimicrobial Agents and Chemotherapy
Scientific articles
8 Sep 2025

Quantifying anti-trypanosomal treatment effects in chronic indeterminate Chagas disease: a secondary analysis of individual patient data from two proof-of-concept trials

The Lancet Microbe
VIEW ALL

Stay connected

Get our latest news, personal stories, research articles, and job opportunities. 

Linkedin-in Instagram Twitter Facebook-f Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films, and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International license