Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04713787
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-18
First Post:
2021-01-14
Brief Title:
A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults
Sponsor:
Asociacion Benefica Prisma
Organization:
Asociacion Benefica Prisma
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 111 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 111 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND158335 | OTHER | FDA | None |
| HHSN272201300020I | None | None | None |