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

Primary Purpose

Trichuris Infection

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Oxfendazole

Albendazole

About this trial

This is an interventional treatment trial for Trichuris Infection focused on measuring oxfendazole, albendazole, Trichuris trichiura

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

OXF6

OXF15

OXF30

OXF15x3

ALB400

Arm Description

Patients receive a single 6 mg/kg dose of oxfendazole administered orally.

Patients receive a single 15 mg/kg dose of oxfendazole administered orally.

Patients receive a single 30 mg/kg dose of oxfendazole administered orally.

Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.

Patients receive a single 400 mg/kg dose of albendazole administered orally.

Outcomes

Primary Outcome Measures

cure d14

absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

cure d7

absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT03435718

First Posted

February 2, 2018

Last Updated

September 26, 2022

Sponsor

Oxfendazole Development Group

Collaborators

Universidad Peruana Cayetano Heredia, Lima, Peru

1. Study Identification

Unique Protocol Identification Number

NCT03435718

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 2023 (Anticipated)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oxfendazole Development Group

Collaborators

Universidad Peruana Cayetano Heredia, Lima, Peru

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trichuris Infection

Keywords

oxfendazole, albendazole, Trichuris trichiura

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Each patient's treatment condition will be masked by a code assigned at randomization. The study pharmacist will know this assignment. A person other than the investigator will administer the drug as directed by the pharmacists.

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OXF6

Arm Type

Experimental

Arm Description

Patients receive a single 6 mg/kg dose of oxfendazole administered orally.

Arm Title

OXF15

Arm Type

Experimental

Arm Description

Patients receive a single 15 mg/kg dose of oxfendazole administered orally.

Arm Title

OXF30

Arm Type

Experimental

Arm Description

Patients receive a single 30 mg/kg dose of oxfendazole administered orally.

Arm Title

OXF15x3

Arm Type

Experimental

Arm Description

Patients receive a 15 mg/kg dose of oxfendazole administered orally once a day for each of three consecutive days.

Arm Title

ALB400

Arm Type

Active Comparator

Arm Description

Patients receive a single 400 mg/kg dose of albendazole administered orally.

Intervention Type

Drug

Intervention Name(s)

Oxfendazole

Intervention Description

oral suspension

Intervention Type

Drug

Intervention Name(s)

Albendazole

Intervention Description

tablet

Primary Outcome Measure Information:

Title

cure d14

Description

absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

Time Frame

Day 14 of follow up

Title

cure d7

Description

absence of eggs of Trichuris trichiura (determined by the Kato Katz method) in stool samples of treated patients

Time Frame

Day 7 of follow up

Secondary Outcome Measure Information:

Title

improvement d21

Description

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

Time Frame

Day 21 of follow up

Title

improvement d14

Description

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

Time Frame

Day 14 of follow up

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d7

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Day 7 of follow up

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d14

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Day 14 of follow up

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, d21

Description

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Day 21 of follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ellen codd, MS

Phone

484 557 3831

ellen.codd@oxfendazoledevelopmentgroup.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Héctor Hugo Garcia, MD PhD

Organizational Affiliation

Oxfendazole Development Group

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

The data will be uploaded to the clinicaltrials.gov website, and a publication will be prepared

Learn more about this trial

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

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