Can a livestock dewormer beat whipworm in people? a trial puts oxfendazole to the test.
NCT ID NCT04713787
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether a single dose of the experimental drug oxfendazole can cure whipworm (Trichuris trichiura) infection better than the standard treatment albendazole. About 249 adults in Peru, where whipworm is common, will receive either 400 mg or 800 mg of oxfendazole or 400 mg of albendazole. The main goal is to see which dose clears the infection, measured by the absence of worm eggs in stool samples.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oxfendazole, an experimental anti-parasitic drug
- What this could lead to
- If oxfendazole proves more effective than albendazole, it could offer a new, single-dose cure for whipworm infections.
- What could go wrong
- This is an early phase 2 trial, so the drug may not work better than the existing treatment. Side effects and optimal dosing are still being explored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 249 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2024
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Trichuriasis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Policlinico Asociacion Benefica Prisma
RECRUITINGSanta Clara, Maynas, Peru
More trials for these conditions
Other studies related to the condition(s) this trial covers.