A multicentre, randomised, non-inferiority clinical trial comparing a nifurtimox-eflornithine combination to standard eflornithine monotherapy for late stage Trypanosoma brucei gambiense human African trypanosomiasis in Uganda

Parasites & Vectors
Freddie KansiimeEnock Matovu

Abstract

While the combination of nifurtimox and eflornithine (NECT) is currently recommended for the treatment of the late stage human African trypansomiasis (HAT), single-agent eflornithine was still the treatment of choice when this trial commenced. This study intended to provide supportive evidence to complement previous trials. A multi-centre randomised, open-label, non-inferiority trial was carried out in the Trypanosoma brucei gambiense endemic districts of North-Western Uganda to compare the efficacy and safety of NECT (200 mg/kg eflornithine infusions every 12 h for 7 days and 8 hourly oral nifurtimox at 5 mg/kg for 10 days) to the standard eflornithine regimen (6 hourly at 100 mg/kg for 14 days). The primary endpoint was the cure rate, determined as the proportion of patients alive and without laboratory signs of infection at 18 months post-treatment, with no demonstrated trypanosomes in the cerebrospinal fluid (CSF), blood or lymph node aspirates, and CSF white blood cell count < 20 /μl. The non-inferiority margin was set at 10%. One hundred and nine patients were enrolled; all contributed to the intent-to-treat (ITT), modified intent-to-treat (mITT) and safety populations, while 105 constituted the per-protocol population (P...Continue Reading

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Citations

Aug 29, 2018·ChemMedChem·Gregorio CulliaAndrea Pinto
Feb 13, 2020·Parasitology·Claudio A PereiraEdward Valera-Vera
Feb 11, 2020·Current Pharmaceutical Design·Vasiliki PardaliGrigoris Zoidis
Feb 6, 2020·Frontiers in Cellular and Infection Microbiology·Nathan Michael ChasenRonald Drew Etheridge
Jan 23, 2020·Tropical Medicine and Infectious Disease·Harry P De Koning
Feb 3, 2021·Infection and Immunity·Adwaita R Parab, Laura-Isobel McCall
Jun 19, 2021·Frontiers in Molecular Biosciences·Satabdi Datta Choudhury
Dec 7, 2018·Chemical Reviews·Yih Ching OngGilles Gasser
Dec 10, 2021·The Cochrane Database of Systematic Reviews·Vittoria LutjeGemma Villanueva

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