A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
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ClinicalTrials.gov Identifier: NCT04713787 |
Recruitment Status :
Not yet recruiting
First Posted : January 19, 2021
Last Update Posted : September 18, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 14, 2021 | ||||||||
First Posted Date ICMJE | January 19, 2021 | ||||||||
Last Update Posted Date | September 18, 2023 | ||||||||
Estimated Study Start Date ICMJE | October 1, 2023 | ||||||||
Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Number of infection cures (Clinical Cure) as shown by absence of Trichuris trichiura eggs using the Kato-Katz stool examination method [ Time Frame: Day 18 through Day 23 ] As measured in each oxfendazole dose group compared to the albendazole dose group. Calculated from two stools samples (each evaluated in duplicate).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults | ||||||||
Official Title ICMJE | A Phase 2, Partially-Blinded, Randomized, Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole for the Treatment of Trichuris Trichiura Infection in Adults | ||||||||
Brief Summary | This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method. | ||||||||
Detailed Description | This is a Phase 2 trial to evaluate the efficacy of different doses of oxfendazole versus a single dose of albendazole in curing or reducing the egg burden in subjects with T. trichiura infections. 249 subjects will be randomized in a 1:1:1 ratio to one of three dose-groups to receive a single dose of oxfendazole 400 mg or 800 mg, or a single dose of albendazole 400 mg. Water and a snack will be provided to aid in ingestion of the study product and a study team member will observe the ingestion of study product. The study team members and study subjects will not be blinded to the dose group. However, the laboratory assessors evaluating the stool samples will be blinded. Subjects will be recruited in Iquitos, Peru, and surrounding villages where there is a high prevalence of T. trichiura infection. Subjects will be solicited through town hall meetings and local clinics and through recommendations from local care providers. A two-stage screening process will be utilized. If subjects are found on the screening stool exam to have only a stool parasite other than T. trichuria or if the subject chooses not to participate in the study, the subject will be referred to a local health provider. If stool analysis performed at the end of the study period demonstrates stool parasites, the subjects will be contacted and referred to their local health provider where they will receive standard of care treatment. The primary objective is to assess the cure rate of different dose regimens of oxfendazole vs. albendazole in the treatment of T. trichiura infections using the Kato-Katz stool examination method. The secondary objectives are to: 1) assess the cure rate of different dose regimens of oxfendazole vs albendazole in the treatment of T. trichiura infections using the stool concentration examination method, 2) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the Kato-Katz stool examination method, 3) assess the clinical response compared to baseline, as shown by reduction in T. trichiura egg counts using the stool concentration method, 4) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the Kato-Katz stool examination method, 5) assess the proportion of subjects with moderate or heavy infection before treatment who had no infection or only light infection after treatment using the stool concentration examination method, 6) establish the spectrum of activity of oxfendazole against other intestinal helminths using the Kato-Katz stool examination method, 7) establish the spectrum of activity of oxfendazole against other intestinal helminths using the stool concentration examination method, 8) assess the tolerability of each oxfendazole dose group compared to the albendazole dose group, and 9) assess the safety in subjects treated with oxfendazole. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Masking Description: This study is masked only to the laboratory personnel. All stool samples, labelled only with a barcode and the date of sample collection by the study team will be evaluated by blinded laboratory staff and will remain blinded until locked. Primary Purpose: Treatment
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Condition ICMJE | Trichuriasis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
249 | ||||||||
Original Estimated Enrollment ICMJE |
250 | ||||||||
Estimated Study Completion Date ICMJE | December 1, 2025 | ||||||||
Estimated Primary Completion Date | October 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Peru | ||||||||
Removed Location Countries | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04713787 | ||||||||
Other Study ID Numbers ICMJE | 18-0004 HHSN272201300020I IND158335 ( Other Identifier: FDA ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Asociacion Benefica Prisma | ||||||||
Original Responsible Party | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Current Study Sponsor ICMJE | Asociacion Benefica Prisma | ||||||||
Original Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | Asociacion Benefica Prisma | ||||||||
Verification Date | September 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |