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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
630
co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID)
HGR (General Reference Hospital) Bandundu
Bandundu, Bandundu, Republic of the Congo
HGR (General Reference Hospital) Kwamouth
Kwamouth, Bandundu, Republic of the Congo
HGR (General Reference Hospital) Yasa Bonga
Yasa Bonga, Bandundu, Republic of the Congo
CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda
Katanda, East Kasai, Republic of the Congo
CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital
Mbuji Mayi, East Kasai, Republic of the Congo
HGR (General Reference Hospital) Ngandajika
Ngandajika, East Kasai, Republic of the Congo
Proportion of patients discharged alive from the hospital or the treatment center
Incidence of serious AE (SAE) and severe AE (CTC score 3 and 4) related to treatment, and overall frequency and nature of AE and need for additional medications to manage these.
Time frame: up to 24 months after treatment
Effectiveness: The clinical cure rate (Survival without clinical and/or parasitological signs of HAT)
Time frame: 24 months after treatment
Number of temporary treatment interruptions, number of premature treatment cessations, length of hospitalization stay (including observation period), treatment compliance (deviation in dosing), and other feasibility indicators.
Time frame: during the treatment/hospitalisation time
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