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Not yet recruiting NCT03435718

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

Phase II Interventional Trichuris Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oxfendazole, Albendazole.
Who it may be relevant to
Registry conditions: Trichuris Infection. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Interventions

  • Drug Oxfendazole
    oral suspension
  • Drug Albendazole
    tablet

Primary outcome measures

  • cure d14 [Time frame: Day 14 of follow up]
  • cure d7 [Time frame: Day 7 of follow up]
Secondary outcome measures (5)
  • improvement d21 [Time frame: Day 21 of follow up]
  • improvement d14 [Time frame: Day 14 of follow up]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7 [Time frame: Day 7 of follow up]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14 [Time frame: Day 14 of follow up]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21 [Time frame: Day 21 of follow up]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT03435718 · OXF2 v3.21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗