Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Summary

This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status. Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 18 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms. Treatment compliance, feasibility, and packaging acceptability will be thoroughly assessed in the participants receiving treatment at home. Those participants will complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.

Timeline

Start

2016-11-10

Primary completion

2021-02-01

Completion

2021-02-01

Publications

• Background WHO. Human African trypanosomiasis: update of the methodological framework for clinical trials: report of the first meeting of the Development of New Tools subgroup, Geneva, 24 September 2014. World Health Organization 2015. WHO/HTM/NTD/IDM/2015.5
• Kumeso VKB, Perdrieu C, Menetrey C, Kyhi MIW, Tete DN, Camara M, Tampwo J, Kavunga P, Camara ML, Kourouma A, Mindele WK, Masa FA, Mahenzi H, Makaya J, Malu TM, Mandula G, Nzambi DMM, Ntoya SL, Reymondier A, Kalonji WM, Scherrer B, Mordt OV. Effectiveness and safety of fexinidazole for gambiense human African trypanosomiasis and exploration of adherence in outpatients: a phase 3b, prospective, open-label, non-randomised, cohort study. Lancet Glob Health. 2025 May;13(5):e900-e909. doi: 10.1016/S2214-109X(24)00526-6.

Drugs

Indications