Clinical Study to Assess the Tolerability, Feasibility and Effectiveness of Nifurtimox and Eflornithine (NECT) for the Treatment of Trypanosoma Brucei Gambiense Human African Trypanosomiasis (HAT) in the Meningo-encephalitic Phase (NECT-FIELD)
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.
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).
- Assess the clinical response of the NECT co-administration under field conditions.
- 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.
|Human African Trypanosomiasis||Drug: Nifurtimox-Eflronithine Combination Treatment (NECT)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ]
|Study Start Date:||April 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Drug: Nifurtimox-Eflronithine Combination Treatment (NECT)
- nifurtimox (Lampit)
- eflornithine (Ornidyl)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00906880
|HGR (General Reference Hospital) Kwamouth|
|Kwamouth, Bandundu, Congo|
|HGR (General Reference Hospital) Yasa Bonga|
|Yasa Bonga, Bandundu, Congo|
|CDTC (Centre de Dépistage, Traitement et Contrôle) Katanda|
|Katanda, East Kasai, Congo|
|CRT (Centre de Réference et de Traitement) Dipumba, Dipumba general hospital|
|Mbuji Mayi, East Kasai, Congo|
|HGR (General Reference Hospital) Ngandajika|
|Ngandajika, East Kasai, Congo|
|HGR (General Reference Hospital) Bandundu|
|Principal Investigator:||Johannes Blum, MD||Swiss Tropical & Public Health Institute|
|Principal Investigator:||Victor Kande, MD||PNLTHA-DRC;|