Not Yet RecruitingPhase 2

Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults

250 participantsStarted 2024-07

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Male or female outpatient, more than 18 years and less than 65 years of age.
✓. Written or witnessed oral informed consent has been obtained.

Exclusion criteria

✕. Willingness to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
✕. Female patients of child bearing potential, who are using an established method of birth control (surgically sterile, intra-uterine contraceptive device, oral contraceptives, diaphragm in combination with contraceptive cream or foam, or condom in combination with contraceptive cream or foam) may be included
✕. The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
✕. Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
✕. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
✕. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
✕. The patient has received an investigational drug within 30 days or 5 half-lives (whichever is longer) of the screening visit or is scheduled to receive such a drug during the study period.
✕. The patient has a concomitant infection or any other underlying disease that would compromise the diagnosis and the evaluation of the response to the study medication.

What they're measuring

cure d14

Timeframe: Day 14 of follow up

cure d7

Timeframe: Day 7 of follow up

Trial details

NCT IDNCT03435718

SponsorOxfendazole Development Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

ellen codd, MS

484 557 3831 ellen.codd@oxfendazoledevelopmentgroup.org

View on ClinicalTrials.gov More Trichuris Infection trials