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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Trichuris Infection

Intervention / Treatment
-----------------
* Drug: Oxfendazole
* Drug: Albendazole


Participation Criteria
=================
Eligibility Criteria
-----------------
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. 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. 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 Exclusion Criteria: 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. 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. 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). The patient is unwilling or unable to take part in this study. The patient has previously been enrolled in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will be conducted as a field trial. Patients will be randomly assigned to one of five treatment groups: 6 mg/kg, 15 mg/kg or 30 mg/kg oxfendazole as a single dose; 15 mg/kg oxfendazole on three consecutive days; or 400 mg albendazole as a single dose (50 patients per group). The main objective of this study is to assess the efficacy (Cure Rate) of oral oxfendazole. Secondary objectives are to assess the Egg Reduction Rate for Trichuris in those subjects not cured of infection, to assess the efficacy (Cure Rate and Egg Reduction Rate) of oxfendazole against other common intestinal helminth infections, and to assess the safety and tolerability of oxfendazole treatment in adult patients.
Masking: Quadruple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oxfendazole, albendazole, Trichuris trichiura