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

Trichuris Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03435718
• Other study ID #: OXF2 v3.21
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: Oxfendazole Development Group
• Contact: ellen codd, MS
• Phone: 484 557 3831
• Email: ellen.codd[@]oxfendazoledevelopmentgroup.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: October 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Trichuriasis
• Trichuris Infection

Intervention

Drug:
• Oxfendazole
oral suspension
• Albendazole
tablet

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oxfendazole Development Group	Universidad Peruana Cayetano Heredia, Lima, Peru

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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