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

Launched by OXFENDAZOLE DEVELOPMENT GROUP · Feb 9, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called oxfendazole for treating an infection caused by a parasite known as Trichuris trichiura, which is commonly found in the intestines. The researchers will also look at how well oxfendazole works against other similar parasites that can affect people. The main goal is to see how different doses of the medication perform, as well as to gather information about its safety and how well patients tolerate it.

To participate in this study, adults aged 18 to 64 who have been diagnosed with a Trichuris trichiura infection confirmed by stool tests may be eligible. Participants will need to provide four stool samples during the study and agree to follow the study's guidelines. Women of childbearing age must be using reliable birth control. It's important to note that individuals with certain health conditions or those who have recently taken other medications may not qualify. Those who join the study will help researchers understand how effective and safe oxfendazole is for treating this type of infection.

Gender

ALL

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.