Procedures
anaemia, helminth infections, Cancer
ANAEMIA, ADVERSE EVENT, ADVERSE EVENTS, HELMINTH INFECTIONS, CANCER
Participants were asked to provide two stool samples at baseline on two consecutive days, with a maximum 5-day interval. Kato-Katz thick smears using 41·7 mg of stool were prepared in duplicate for each sample and assessed by experienced laboratory technicians under a light microscope. Egg counts of Participants received either 8 mg moxidectin and 400 mg albendazole (group 1), 200 μg/kg ivermectin and 400 mg albendazole (group 2), 400 mg albendazole (group 3), 200 μg/kg ivermectin (group 4), or 8 mg moxidectin (group 5). Moxidectin (Medicines Development for Global Health, Melbourne, VIC, Australia) was available in tablets of 2 mg with participants receiving 4 tablets each. Ivermectin (Merck Sharp & Dohme, Readington, NJ, USA) was administered in 3 mg tablets as a weight-dependent dose. Albendazole (GlaxoSmithKline, London, UK) was given as a single tablet of 400 mg.On the treatment day, study physicians performed a physical examination (including a rapid assessment of haemoglobin concentrations to rule out anaemia, measurement of body temperature, and the medical history to assess baseline conditions) of all eligible participants to ensure inclusion criteria were met. Females were tested for pregnancy and asked to confirm that no pregnancy was planned throughout the duration of the study. Study physicians assessed adverse events at 3 h and 24 h after treatment. At the three follow-up timepoints of 14–21 days, 5–6 weeks, and 3 months after treatment, adverse events were assessed retrospectively by trained study team members and considered as possibly related when causality could not be ruled out by other conditions. Severity grading was categorised according to the US National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE; version 5.0).A subsample of 60 participants were asked to provide blood samples collected by a finger prick for the assessment of pharmacokinetic parameters between day 0 and 7 after treatment. Pharmacokinetic results will be published elsewhere. Efficacy was assessed 14–21 days after treatment by quadruplicate Kato-Katz from two stool samples collected using the same procedures as for baseline sampling. The same procedures were applied at the other timepoints to determine long-term treatment efficacy. At the end of the study, participants who were still positive for soil-transmitted helminth infections were offered the best available treatment option—ie, ivermectin and albendazole.