The main objective of this study is to provide data on the efficacy profile of different doses of oxfendazole when used in Trichuris trichiura infection. The drug will be also be examined for efficacy against other common nematodes encountered in man (Ascaris lumbricoides, Ancylostoma duodenale, Necator americanus). The study will also provide data on the safety and tolerability of the oxfendazole in patients.
This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
oral suspension
tablet
cure d14
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Time frame: Day 14 of follow up
cure d7
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Time frame: Day 7 of follow up
improvement d21
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Time frame: Day 21 of follow up
improvement d14
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Time frame: Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Day 7 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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Time frame: Day 21 of follow up