Clinical trial NCT03435718: Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Trichuris Infection
Keywords: oxfendazole
albendazole
Trichuris trichiura
Lead sponsor: Oxfendazole Development Group
Sponsor class: OTHER
Collaborators: name: Universidad Peruana Cayetano Heredia, Lima, Peru
First posted: 2018-02-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: cure d14
timeFrame: Day 14 of follow up
measure: cure d7
timeFrame: Day 7 of follow up
Secondary outcomes:
measure: improvement d21
timeFrame: Day 21 of follow up
measure: improvement d14
timeFrame: Day 14 of follow up
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7
timeFrame: Day 7 of follow up
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14
timeFrame: Day 14 of follow up
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21
timeFrame: Day 21 of follow up
Other outcomes:
Locations:
Study officials:
affiliation: Oxfendazole Development Group
name: Héctor Hugo Garcia, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: