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
Sponsored by
About this trial
This is an interventional treatment trial for Trichuris Infection focused on measuring oxfendazole, albendazole, Trichuris trichiura
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
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
No
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
No
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
Email
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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