Comparing oxfendazole and albendazole for treating Trichuris trichiura infections in adults

A Phase 2, Partially-Blinded, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole for the Treatment of Trichuris Trichiura Infection in Adults

This study is testing whether different doses of a new medication called oxfendazole can treat Trichuris trichiura infections in adults better than the standard treatment with albendazole.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 249 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Asociacion Benefica Prisma (other)
• Locations: 1 site (Santa Clara de Nanay, Maynas)
• Trial ID: NCT04713787 on ClinicalTrials.gov

What this trial studies

This Phase 2 trial evaluates the efficacy of different doses of oxfendazole compared to a single dose of albendazole in treating Trichuris trichiura infections in adults. A total of 249 participants will be randomized into three groups to receive either 400 mg or 800 mg of oxfendazole, or 400 mg of albendazole. The study will take place in Iquitos, Peru, where there is a high prevalence of the infection, and will involve a two-stage screening process to ensure participants meet eligibility criteria. The primary objective is to assess the cure rate and reduction of egg burden in stool samples post-treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-65 who have a confirmed diagnosis of Trichuris trichiura infection.

Not a fit: Patients who do not have Trichuris trichiura infection or have other unrelated stool parasites may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from Trichuris trichiura infections.

How similar studies have performed: Other studies have shown success with similar approaches in treating parasitic infections, but the specific use of oxfendazole for this condition is novel.

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.

Where this trial is running

Santa Clara de Nanay, Maynas

• Policlinico Asociacion Benefica Prisma — Santa Clara de Nanay, Maynas, Peru (RECRUITING)

Study contacts

• Study coordinator: Patricia L. Winokur

Conditions: Trichuriasis, Adults, Albendazole, Comparative Study, Efficacy, Oxfendazole, Phase 2, Trichuris trichiura