This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method.
Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.
Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.
Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).
Has a diarrheal disease that would interfere with the evaluation of stool samples*.
Has received an antihelminthic within 14 days before enrolment.
Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
Map coordinates are unavailable for these locations. Locations are shown below instead.
PeruAsociacion Benefica Prisma
Lead sponsor
Policlinico Asociacion Benefica PRISMA-Laboratorio Satelite IQTLAB
Collaborator
National Institutes of Health (NIH)
Collaborator
University of Iowa
Collaborator
University of Virginia
Collaborator