Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults

An Open 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 aim of this study is to provide data on the efficacy of oxfendazole against Trichuris trichiura at different doses in comparison to the standard single 400 mg dose of albendazole. In addition, the study will provide data on oxfendazole efficacy against other common nematodes encountered in man (Enterobius vermicularis, Ascaris lumbricoides, Ancylostoma duodenalis, Necator americanus).

Study Overview

• Status: Withdrawn
• Conditions: Helminthiasis
• Intervention / Treatment: Drug: oxfendazole; Drug: albendazole

Detailed Description

This is an open, comparative study in adult patients with proven intestinal infection with Trichuris trichiura. Patients meeting the study entry criteria will receive either 6mg/kg, or 30 mg/kg of oxfendazole as a single oral dose or 6 mg/kg orally for three days or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined 7, 14 and 21 days after treatment.

Two hundred clinically evaluable patients of either gender, 16 - 65 years of age, presenting with proven Trichuris trichiura infection, recruited from one centre, will be included in the study. there will be 15 patients in each treatment group. Duration of accrual will be determined in discussion with the clinical site in Iquitos, Peru.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Written or witnessed oral informed consent has been obtained.
2. Has Trichuris trichiura demonstrated in stool samples obtained during the week before enrolment: The presence of other helminths: Enterobius vermicularis, Ascaris lumbricoides, Necator americanus, Ancylostoma duodenalis will not be a cause for exclusion.
3. Is willing to comply with the requirements of the protocol and particularly to provide 4 stool samples, pretreatment and 7, 14 and 21 days after treatment.
4. 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)

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. Note: 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 (plasma creatinine ≥ 1.5 times upper limit of normal for age) or hepatic dysfunction (liver enzymes ≥ 1.5
8. 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. Patient that 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: FACTORIAL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: oxfendazole 6 mg/kg; patients receive 6 mg/kg oxfendazole once	Drug: oxfendazole; group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
EXPERIMENTAL: oxfendazole 30 mg/kg; patients receive 30 mg/kg oxfendazole once	Drug: oxfendazole; group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
EXPERIMENTAL: oxfendazole 6 mg/kg 3 times; patients receive 6 mg/kg oxfendazole three times	Drug: oxfendazole; group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
ACTIVE_COMPARATOR: albendazole 400 mg; patients receive 400 mg albendazole once	Drug: albendazole; group receives one 400 mg dose of albendazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of Trichuris trichiura	Cure of infection (Clinical Cure) shown by absence of Trichuris eggs in stool examinations at Day 21, using Kato Katz test.	day 21 following treatment
Reduction in Trichuis trichiura eggs (compared to pretreatment)	Reduction (compared to baseline) of Trichuris eggs in stool examinations at 21, using Kato Katz test.	day 21 following treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cure of other intestinal helminths	Absence of Ascaris, Necator eggs in stool using Kato Katz test	day 21 following treatment
Safety and tolerability of oxfendazole in the treatment of adult patients assessed by cumulative adverse events	Cumulative adverse events following treatment up to Day 21	treatment through day 21 following treatment

Collaborators and Investigators

• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Universidad Peruana Cayetano Heredia
• Investigators: Principal Investigator: Hector H Garcia, MD, PhD, Universidad Peruana Cayetano Heredia; Principal Investigator: Richard J Horton, MB BChir, MRCGP, FFPM, Tropical Projects; Principal Investigator: Armando E Gonzalez, DVM, PhD, National University of San Marcos, Peru

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): February 1, 2021

Study Registration Dates

• First Submitted: December 14, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (ESTIMATE): December 22, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Ascaris; trichuris; hookworms
• Additional Relevant MeSH Terms: Infections; Parasitic Diseases; Nematode Infections; Enoplida Infections; Adenophorea Infections; Helminthiasis; 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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: posting to CT.gov and publication

Drug and device information, study documents

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