Overview

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

Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Oxfendazole Development Group
Collaborator:
Universidad Peruana Cayetano Heredia, Lima, Peru
Treatments:
Albendazole
Oxfendazole
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.