The aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).
This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment. Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
group receives one 400 mg dose of albendazole
Cure of Trichuris trichiura
Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.
Time frame: day 21 following treatment
Reduction in Trichuis trichiura eggs (compared to pretreatment)
Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.
Time frame: day 21 following treatment
Cure of other intestinal helminths
Absence of Ascaris, Necator eggs in stool using Kato Katz test
Time frame: day 21 following treatment
Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events
Cumulative adverse events following treatment up to Day 21
Time frame: treatment through day 21 following treatment
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