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

Phase 2

Not yet recruiting

• Conditions: Trichuris Infection
• Interventions: Drug: Oxfendazole; Drug: Albendazole

• Registration Number: NCT03435718
• Lead Sponsor: Oxfendazole Development Group

Brief 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.

Detailed 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, 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.

Study Timeline

• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-08
• Study Start: 2024-07
• Primary Completion: 2026-07
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. Male or female outpatient, more than 18 years and less than 65 years of age.
2. Written or witnessed oral informed consent has been obtained.
3. Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis or other helminths will not be a cause for exclusion.
4. 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.
5. 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

Exclusion Criteria

1. The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
2. Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
3. The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
4. The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
5. 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.
6. 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.
7. The patient has a known history of renal dysfunction or plasma creatinine ≥ 1.5 times upper limit of normal for age or a known history of hepatic dysfunction or liver enzymes ≥ 1.5 times upper limit of normal.
8. The patient is a female who is pregnant, lactating or planning a pregnancy during the study, or is not practicing any form of contraception (see inclusion criteria (4.2.5).
9. The patient is unwilling or unable to take part in this study.
10. The patient has previously been enrolled in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OXF6	Oxfendazole	Patients receive a single 6 mg/kg dose of oxfendazole administered orally.
OXF15	Oxfendazole	Patients receive a single 15 mg/kg dose of oxfendazole administered orally.
OXF30	Oxfendazole	Patients receive a single 30 mg/kg dose of oxfendazole administered orally.
OXF15x3	Oxfendazole	Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.
ALB400	Albendazole	Patients receive a single 400 mg/kg dose of albendazole administered orally.

Primary Outcome Measures

Name	Time	Method
cure d14	Day 14 of follow up	absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
cure d7	Day 7 of follow up	absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

Secondary Outcome Measures

Name	Time	Method
improvement d21	Day 21 of follow up	reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
improvement d14	Day 14 of follow up	reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7	Day 7 of follow up	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14	Day 14 of follow up	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21	Day 21 of follow up	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0