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

Autor: Freddie Kansiime, Seraphine Adibaku, Charles Wamboga, Franklin Idi, Charles Drago Kato, Lawrence Yamuah, Michel Vaillant, Deborah Kioy, Piero Olliaro, Enock Matovu
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: Parasites & Vectors, Vol 11, Iss 1, Pp 1-11 (2018)
Druh dokumentu: article
ISSN: 1756-3305
DOI: 10.1186/s13071-018-2634-x
Popis: Abstract Background 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. Methods 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
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