protocolSection identificationModule nctId: NCT06367361, orgStudyIdInfo id: SIDISI 201221, secondaryIdInfos id: U01AI155323, type: NIH, link: https://reporter.nih.gov/quickSearch/U01AI155323, briefTitle: One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07, primaryCompletionDateStruct date: 2028-03, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Universidad Peruana Cayetano Heredia, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: 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. Children and 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 PK modeling studies will be performed in the first 24 hours after the first dose of oxfendazole., conditionsModule conditions: Fascioliasis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Study arm 1: Oxfendazole 100 mg tablets at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.Study arm 2: Oxfendazole 100 mg tablets at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint., whoMasked: CARE_PROVIDER, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 336, type: ESTIMATED, armsInterventionsModule interventions name: Oxfendazole, interventions name: Triclabendazole, outcomesModule primaryOutcomes measure: Parasitological cure rate of chronic fascioliasis, primaryOutcomes measure: Egg reduction rate day 7, primaryOutcomes measure: Egg reduction rate day 30, secondaryOutcomes measure: Safety information on day 0, secondaryOutcomes measure: Safety information on day 3, secondaryOutcomes measure: Safety information on day 7, secondaryOutcomes measure: Safety information on day 30, secondaryOutcomes measure: Laboratory safety information day 7, secondaryOutcomes measure: Laboratory safety information day 30, secondaryOutcomes measure: Population pharmacokinetics model constructs for oxfendazole, secondaryOutcomes measure: Population pharmacokinetics model constructs for oxfendazole sulfone, secondaryOutcomes measure: Population pharmacokinetics model constructs fenbendazole, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 65 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False