| Trial name or title |
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2 |
| Methods |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind |
| Participants |
15 years old or more, male or female, with Karnofsky index>50, with parasitologically confirmed late‐stage African trypanosomiasis infection with T. b. gambiense in the blood and/or lymph and/or CSF, or WBC >20/µL detected in the CSF to document stage 2 infection. |
| Interventions |
Fexinidazole Compared to Nifurtimox‐Eflornithine Combination Therapy |
| Outcomes |
success or failure at 18 months follow‐up visit |
| Starting date |
September 2012 |
| Contact information |
Antoine Tarral (DNDi), Victor Kande, HAT National Control Program in DRC. |
| Notes |
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