Trichuris InfectionPhase 2NCT03435718
Efficacy of Oxfendazole in the Treatment of Trichuris Trichiura Infection in Adults
A Phase 2 study testing Oxfendazole and Albendazole in people with Trichuris Infection, run by Oxfendazole Development Group.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichuris Infection
- What is being tested?
- Oxfendazole and Albendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Oct 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatient, more than 18 years and less than 65 years of age.
- Written or witnessed oral informed consent has been obtained.
- 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.
- 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.
- 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
Who cannot join
- The patient has demonstrated a previous hypersensitivity reaction to benzimidazole or other related compound.
- Presence of other helminths without Trichuris trichiura. Non-target species may be present and details of response will be recorded.
- The patient has diarrhoeal disease that would interfere with the evaluation of stool samples.
- The patient has received an anthelminthic in the 2 weeks prior to enrolment into the study.
- 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.
- 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.
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- 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.
- 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).
- The patient is unwilling or unable to take part in this study.
- The patient has previously been enrolled in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Assessor Blind, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
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.
Read the detailed description
This is an assessor blind, randomized, comparative study in adult patients with proven intestinal infection with Trichuris trichiura to be conducted as a field study. Patients meeting the study entry criteria will receive either 6 mg/kg or 15 mg/kg or 30 mg/kg of oxfendazole as a single oral dose, three single doses of oxfendazole on consecutive days, or albendazole 400mg as a single oral dose. Stool samples will be obtained and examined prior to treatment and at 7, 14 and 21 days after treatment.
- Conditions
- Trichuris Infection
- Being tested
- Oxfendazole, Albendazole
- Keywords
- oxfendazole, albendazole, Trichuris trichiura
- Medical subject headings
- Trichuriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxfendazoleDrug
oral suspension
AlbendazoleDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| OXF6 | Experimental | Patients receive a single 6 mg/kg dose of oxfendazole administered orally. Receives: Drug: Oxfendazole |
| OXF15 | Experimental | Patients receive a single 15 mg/kg dose of oxfendazole administered orally. Receives: Drug: Oxfendazole |
| OXF30 | Experimental | Patients receive a single 30 mg/kg dose of oxfendazole administered orally. Receives: Drug: Oxfendazole |
| OXF15x3 | Experimental | Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days. Receives: Drug: Oxfendazole |
| ALB400 | Active comparator | Patients receive a single 400 mg/kg dose of albendazole administered orally. Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure d14
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Measured: Day 14 of follow up
cure d7
absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Measured: Day 7 of follow up
Secondary outcomes (5)
improvement d21
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Measured: Day 21 of follow up
improvement d14
reduction (with respect to the baseline count of that individual) in number of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients
Measured: Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Day 7 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Day 14 of follow up
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Day 21 of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startJul 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trichuris InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted as a field trial. Patients will be randomly assigned to one of five treatment groups: 6 mg/kg, 15 mg/kg or 30 mg/kg oxfendazole as a single dose; 15 mg/kg oxfendazole on three consecutive days; or 400 mg albendazole as a single dose (50 patients per group). The main objective of this study is to assess the efficacy (Cure Rate) of oral oxfendazole. Secondary objectives are to assess the Egg Reduction Rate for Trichuris in those subjects not cured of infection, to assess the efficacy (Cure Rate and Egg Reduction Rate) of oxfendazole against other common intestinal helminth infections, and to assess the safety and tolerability of oxfendazole treatment in adult patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxfendazole Development Group
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia
- Responsible party
- Sponsor
- Investigators
- Héctor Hugo Garcia, MD PhD, Principal investigator, Oxfendazole Development Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435718
- Sponsor's protocol ID
- OXF2 v3.21
- Status last verified
- Nov 2023
- First submitted
- 2 Feb 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared