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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Helminthiasis

Intervention / Treatment
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* Drug: oxfendazole
* Drug: albendazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written or witnessed oral informed consent has been obtained. 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. 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. 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: The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound. Presence of other helminths without Trichuris trichiura. Note: 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 (plasma creatinine ≥ 1.5 times upper limit of normal for age) or hepatic dysfunction (liver enzymes ≥ 1.5 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). Patient that is unwilling or unable to take part in this study. The patient has previously been enrolled in the study.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxfendazole 6 mg/kg<br>patients receive 6 mg/kg oxfendazole once | Drug: oxfendazole<br>* group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses<br>|
| Experimental: oxfendazole 30 mg/kg<br>patients receive 30 mg/kg oxfendazole once | Drug: oxfendazole<br>* group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses<br>|
| Experimental: oxfendazole 6 mg/kg 3 times<br>patients receive 6 mg/kg oxfendazole three times | Drug: oxfendazole<br>* group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses<br>|
| Active Comparator: albendazole 400 mg<br>patients receive 400 mg albendazole once | Drug: albendazole<br>* group receives one 400 mg dose of albendazole<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trichuris, hookworms, Ascaris