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

An Assessor Blind, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Trichuris Infection
• Intervention / Treatment: Drug: Oxfendazole; Drug: Albendazole

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ellen codd, MS; Phone Number: 484 557 3831; Email: ellen.codd@oxfendazoledevelopmentgroup.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OXF6; Patients receive a single 6 mg/kg dose of oxfendazole administered orally.	Drug: Oxfendazole; oral suspension
Experimental: OXF15; Patients receive a single 15 mg/kg dose of oxfendazole administered orally.	Drug: Oxfendazole; oral suspension
Experimental: OXF30; Patients receive a single 30 mg/kg dose of oxfendazole administered orally.	Drug: Oxfendazole; oral suspension
Experimental: OXF15x3; Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.	Drug: Oxfendazole; oral suspension
Active Comparator: ALB400; Patients receive a single 400 mg/kg dose of albendazole administered orally.	Drug: Albendazole; tablet

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement d21	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	Day 21 of follow up
improvement d14	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	Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Day 7 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Day 21 of follow up

Collaborators and Investigators

• Sponsor: Oxfendazole Development Group
• Collaborators: Universidad Peruana Cayetano Heredia, Lima, Peru
• Investigators: Principal Investigator: Héctor Hugo Garcia, MD PhD, Oxfendazole Development Group

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: albendazole; Trichuris trichiura; oxfendazole
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Parasitic Diseases; Nematode Infections; Helminthiasis; Enoplida Infections; Adenophorea Infections; Infections; Communicable Diseases; Trichuriasis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Oxfendazole; Albendazole
• Other Study ID Numbers: OXF2 v3.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No