Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Trichuris Infection
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: This study will be conducted as a field trial. Patients will be randomly assigned to one of five treatment groups: 6 mg/kg, 15 mg/kg or 30 mg/kg oxfendazole as a single dose; 15 mg/kg oxfendazole on three consecutive days; or 400 mg albendazole as a single dose (50 patients per group). The main objective of this study is to assess the efficacy (Cure Rate) of oral oxfendazole. Secondary objectives are to assess the Egg Reduction Rate for Trichuris in those subjects not cured of infection, to assess the efficacy (Cure Rate and Egg Reduction Rate) of oxfendazole against other common intestinal helminth infections, and to assess the safety and tolerability of oxfendazole treatment in adult patients.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Each patient's treatment condition will be masked by a code assigned at randomization. The study pharmacist will know this assignment. A person other than the investigator will administer the drug as directed by the pharmacists.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
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, t...
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.
Tracking Information
- NCT #
- NCT03435718
- Collaborators
- Universidad Peruana Cayetano Heredia, Lima, Peru
- Investigators
- Principal Investigator: Héctor Hugo Garcia, MD PhD Oxfendazole Development Group
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