drugset / Trial / NCT00146627
Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis
Phase 3
Completed
280 enrolled
Drugs for Neglected Diseases
Epicentre · collabMedecins Sans Frontieres, Netherlands · collabPNLTHA-DRC; · collabPNLTHA-RoC · collabSwiss Tropical & Public Health Institute · collabWorld Health Organization · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the therapeutic combination of I.V. eflornithine + oral nifurtimox to the standard IV eflornithine regimen in terms of therapeutic efficacy and clinical safety, in patients suffering from Trypanosoma brucei gambiense (Tbg) human African trypanosomiasis (HAT) in the meningoencephalitic phase.
Timeline
- Start
- —
- Primary completion
- 2008-06
- Completion
- 2008-06
Publications
- Background Opigo J, Woodrow C. NECT trial: more than a small victory over sleeping sickness. Lancet. 2009 Jul 4;374(9683):7-9. doi: 10.1016/S0140-6736(09)61163-6. Epub 2009 Jun 24. No abstract available.
- Results Priotto G, Kasparian S, Mutombo W, Ngouama D, Ghorashian S, Arnold U, Ghabri S, Baudin E, Buard V, Kazadi-Kyanza S, Ilunga M, Mutangala W, Pohlig G, Schmid C, Karunakara U, Torreele E, Kande V. Nifurtimox-eflornithine combination therapy for second-stage African Trypanosoma brucei gambiense trypanosomiasis: a multicentre, randomised, phase III, non-inferiority trial. Lancet. 2009 Jul 4;374(9683):56-64. doi: 10.1016/S0140-6736(09)61117-X. Epub 2009 Jun 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eflornithine | Small molecule | 400 mg/kg | Intravenous |
| Subject | Nifurtimox | Small molecule | 15 mg/kg | Oral |