Participants and enrollment
allergic reaction
ALLERGIC REACTION, LIVER DISEASE
The study was conducted in two parts. The first part involved 72 patients enrolled between August 20, 2020 and September 22, 2020. It included inpatient treatment with intensive safety monitoring at the Centre de Recherche de Filariose Lymphatique d’Agboville, located at Centre Hôspitalier Regional d’Agboville, Côte d’Ivoire for the first 72 hours after treatment and at day 7, with passive outpatient safety monitoring in their village on days 4–6. After observing no concerning safety signals from this cohort, the data safety monitoring board approved the prespecified plan to treat the remaining patients in their villages with daily outpatient TEAE monitoring. Subsequent enrollments (part II) took place between December 1, 2020 and July 30, 2021.Eligible participants included healthy adults aged 18–70 years old, with no recent acute illness, and no antifilarial treatment within the past year. Contraception prior to, and for 1 month following, treatment was required for all women of childbearing age. Pregnant or breastfeeding women were excluded. Exclusion criteria included: history of chronic kidney or liver disease; creatinine, serum alanine transaminase or aspartate transaminase level >2 times the upper limits of normal (measured by a portable biochemistry analyzer); blood hemoglobin <7 gm/dL; history of prior allergic reaction to study medications; coinfection with 