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| Name | Class |
|---|---|
| Lao Tropical and Public Health Institute | OTHER_GOV |
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This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel in children infected with Opisthorchis viverrini. The primary objective is to determine the dose-response relationship in terms of cure rate. This study will involve children aged 6-7 years, since O. viverrini infections often occur in pre-school and school-aged children, and this group is largely left untreated in current public health programs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arpraziquantel 30 mg/kg | Experimental | Treatment with a single dose arpraziquantel: 30 mg/kg, orally administered |
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| Arpraziquantel 40 mg/kg | Experimental | Treatment with a single dose arpraziquantel: 40 mg/kg, orally administered |
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| Arpraziquantel 50 mg/kg | Experimental | Treatment with a single dose arpraziquantel: 50 mg/kg, orally administered |
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| Arpraziquantel 60 mg/kg | Experimental | Treatment with a single dose arpraziquantel: 60 mg/kg, orally administered |
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| Arpraziquantel 20 mg/kg | Experimental | Treatment with a single dose arpraziquantel: 20 mg/kg, orally administered |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apraziquantel | Drug | Tablets (dispersible) containing 150 mg arpraziquantel |
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| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of arpraziquantel against O. viverrini | CRs will be calculated as the percentage of O. viverrini egg-positive participants at baseline who become egg-negative after treatment. | 21-28 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg reduction rates (ERR) of arpraziquantel against O. viverrini | Eggs per gram of stool (EPG) will be assessed by calculating the mean egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of 24. Geometric and arithmetic mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. | 21-28 days after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Keiser, PhD | Contact | +41 61 284 82 18 | jennifer.keiser@swisstph.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lao Tropical and Public Health Institute (Lao TPHI) | Vientiane | Laos |
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| Safety and tolerability of the different arpraziquantel dosing regimens, and compared to placebo | Participants will be monitored at the site for 3 hours following treatment for any acute adverse events (AEs). Participants will be interviewed 3 hours and 24 hours after treatment, as well as 21-28 days and 42 days after treatment administration about the occurrence of AEs. AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment. | 3 hours, 24 hours, 21-28 days and 42 days after treatment |