NCT00906880

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 630 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Human African Trypanosomiasis

Interventions

Type	Name	Description
DRUG	Nifurtimox-Eflronithine Combination Treatment (NECT)	co-administration of nifurtimox (10 days, 15 mg/kg/day, p.o. TID) and eflornithine (7 days, 400 mg/kg/day, i.v. BID)

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2013-01-01
• First posted: 2009-05-21
• Last updated: 2013-05-31

Locations

6 sites across 1 country: Republic of the Congo