A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults

Launched by ASOCIACION BENEFICA PRISMA · Jan 14, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating how effective different doses of a medication called oxfendazole are at treating an infection known as trichuriasis, which is caused by a type of worm called Trichuris trichiura. The study will compare two doses of oxfendazole (400 mg and 800 mg) to a standard treatment called albendazole (400 mg). A total of 249 adult participants will be recruited from Iquitos, Peru, where this infection is common. Participants will be randomly assigned to one of the three treatment groups and will be monitored to see how well the medications work in reducing or eliminating the infection.

To be eligible for the trial, participants must be between 18 and 65 years old and need to have a confirmed T. trichiura infection based on a stool sample. They should also be willing to provide several stool and blood samples over a period of about 4 to 6 weeks. Women of childbearing age must have a negative pregnancy test and use effective contraception during the study. Participants will receive regular check-ups, and if they still have other infections after the study, they will be referred to local healthcare providers for standard treatment. This trial aims to find a potentially better treatment option for trichuriasis, which could lead to improved health outcomes for those affected.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18-65 years, inclusive and weigh ≥45 kg.
• • 2. Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.
• • 3. T. trichiura\* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.
• • \*The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.
• • 4. Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples\* over approximately 4- 6 weeks.
• • \*An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.
• • 5. Females must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test 72 hours prior to the first study drug administration.\*ª
• • \*If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -1) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative 72 hours prior to the first study drug administration.
• • ª Pregnancy testing is not required for women of non-childbearing potential
• • 6. Female subjects of childbearing potential must be using effective contraception.\* \*Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged \>/=50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.
• Exclusion Criteria:
• • 1. Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).
• • 2. Has a diarrheal disease that would interfere with the evaluation of stool samples\*.
• • \* More than 6 stools per day or stools that are completely liquid.
• • 3. Has received an antihelminthic within 14 days before enrolment.
• • 4. Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
• • 5. Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.
• • 6. Has a known history of renal dysfunction or plasma creatinine \>/=1.5 times the upper limit of normal (ULN) for age.
• • 7. Has a known history of hepatic dysfunction or AST, ALT, total bilirubin \>/=1.5 times the ULN.
• • 8. Has a hemoglobin that is less than 8 g/dL.
• • 9. Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose).
• • 10. Has previously been enrolled in this trial.
• • 11. Has any condition that would, in the investigator's opinion, interfere with this trial.