NCT02636803.

Trial name or title	An open comparative study of the efficacy of different doses of oxfendazole compared to single dose albendazole in the treatment of Trichuris trichiura infection in adults
Methods	Randomized clinical trial
Participants	Estimated enrolment: 200 Age: 16–65 years Inclusion criteria Written or witnessed oral informed consent obtained Has Trichuris trichiura demonstrated in stool samples obtained during week before enrolment: presence of other helminths: Enterobius vermicularis, Ascaris lumbricoides, Necator americanus, or Ancylostoma duodenale will not be a cause for exclusion Willing to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14, and 21 days after treatment Women of child‐bearing potential, who are using an established method of birth control (surgically sterile, intrauterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam) Exclusion criteria Previous hypersensitivity reaction to benzimidazole or other related compound Presence of other helminths without Trichuris trichiura. Note: non‐target species may be present and details of response will be recorded Presence of diarrhoeal disease that would interfere with the evaluation of stool samples Received an anthelmintic in 2 weeks prior to enrolment into study Received an investigational drug within 30 days or 5 half‐lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period Has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication History of renal dysfunction (plasma creatinine ≥ 1.5 times upper limit of normal for age) or hepatic dysfunction (liver enzymes ≥ 1.5) Pregnant, lactating, or planning a pregnancy during the study, or is not practicing any form of contraception Unwilling or unable to take part in this study Previously been enrolled in the study
Interventions	Group 1: oxfendazole 6 mg/kg or 30 mg/kg single dose or 3 × 6 mg/kg doses Group 2: albendazole 400 mg single dose
Outcomes	Cure of Trichuris trichiura Reduction in Trichuris trichiura eggs Cure of other intestinal helminths (Ascaris, Necator eggs in stool using Kato‐Katz test) Safety and tolerability of oxfendazole in the treatment of adults assessed by cumulative adverse events
Starting date	November 2017
Contact information	Robert H Gilman, rgilman@johnshopkins.edu
Notes	Katz test 21 days following treatment