Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.
Male and female subjects eighteen years or older with positive stool microscopy and/or egg counts confirmed by qualitative and/or quantitative stool microscopy performed within the past 14 days.
Subjects capable of understanding the informed consent process and providing written informed consent.
Willingness to give informed consent.
Subjects reporting previous treatment for fascioliasis
Subjects with a stool egg count > 300 eggs/g in stool samples
Women with a positive urine pregnancy test or planning to become pregnant
Women that are nursing
Parallel
Oxfendazole
DrugHuman studies have shown that doses up to 60 mg/kg (approximately 3.6 g for a 60-kg human, which is considered the average weight of an adult in developing countries) are safe and that repeated doses of 15 mg/kg (approximately 900 mg for a 60-kg human) daily for 5 days are safe. A single dose of OXF results in significant plasma drug concentrations that reach a Cmax plateau after doses of 15 mg/kg.75 The dose to be studied in this trial is 20 mg/kg (1200 mg maximum dose), a dose only slightly higher than that achieving a Cmax plateau. This dose was conservatively selected to account for interindividual variation in plasma levels and deemed well tolerated and safe based on laboratory and ECG evaluations.
Triclabendazole
DrugThe standard of care for the treatment of fascioliasis according to the same guidelines is two 10 mg/kg doses of TCBZ 24 hours apart administered with a fat containing meal. The subjects in one of the arms of the study will receive this treatment as the standard of care. Subjects from any of the arms that fail to achieve parasitological cure will receive rescue treatment off the study with two doses of TCBZ as recommended by the Peruvian guidelines.
Parasitological cure rate of chronic fascioliasis
The cure rate will be expressed as the proportion of subjects in each arm with negative tests for Fasciola eggs.
Egg reduction rate day 7
The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count
Egg reduction rate day 30
The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count
Safety information on day 0
Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
Safety information on day 3
Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
Safety information on day 7
Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
Safety information on day 30
Safety information will be collected using a symptoms questionnaire and expressed as the proportion of subjects with adverse events in each arm.
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Universidad Peruana Cayetano Heredia
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Oxfendazole Development Group
Collaborator
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