Human African Trypanosomiasis Clinical Trial
Official title:
Clinical Study to Assess the Clinical Tolerability, Feasibility and Effectiveness Under Field Conditions of the Combination of Nifurtimox and Eflornithine (NECT) for the Treatment of T.b.Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Stage
Multicenter, open label, uncontrolled phase IIIb study of therapeutic use of the combination
of nifurtimox and eflornithine (NECT) for the treatment of Trypanosoma brucei gambiense
human African trypanosomiasis (HAT) in the meningo-encephalitic phase.
Overall objectives:
Assess the clinical tolerability, feasibility and effectiveness of NECT co-administration to
treat patients with T.b. gambiense human African trypanosomiasis (HAT) in the
meningo-encephalitic phase in actual real-life conditions (regular treatment centers of the
National HAT Control Programme, NGO treatment centers).
Primary objective:
- Assess the clinical response of the NECT co-administration under field conditions.
Secondary objectives:
- Assess the incidence and type of adverse events (AE), and the capacity of the treatment
centers to deal with these.
- Assess the feasibility of the implementation of the NECT coadministration by the health
center.
- Assess the effectiveness of the NECT co-administration at 24* months after treatment.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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