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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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This study aims to provide evidence on the efficacy, safety and acceptability of the new, chewable formulation of oxantel pamoate administered as a single dose or multiple doses, compared to mebendazole in children infected with T. trichiura. This study will involve children aged 2-12 years, since an infection with T. trichiura occurs often in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxantel Single Dose | Experimental | Treatment with oxantel pamoate (20 mg/kg), orally administered on day 0 |
|
| Oxantel Multiple Dose | Experimental | Treatment with oxantel pamoate (20 mg/kg), orally administered on each of day 0, 1 and 2 |
|
| Mebendazole Single Dose | Active Comparator | Mebendazole (500mg), orally administered on day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxantel Pamoate | Drug | Tablets containing 250 mg oxantel pamoate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of oxantel pamoate single dose compared to mebendazole T. trichiura | CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment. | 14-21 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg reduction rate (ERR) of oxantel pamoate single dose compared to mebendazole against T. trichiura | Eggs per gram of stool (EPG) will be assessed by adding up the egg counts from the quadruplicate Kato-Katz thick smears and multiplying this number by a factor of six. Geometric and arithmetic mean egg counts will be calculated for the two treatment arms before and after treatment to assess the corresponding ERRs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Keiser, PhD | Swiss Tropical & Public Health Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Tanzania |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D006725 | Hookworm Infections |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C037225 | oxantel pamoate |
| D008463 | Mebendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Mebendazole | Drug | Tablets containing 500 mg mebendazole |
|
| 14-21 days after treatment |
| Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to oxantel single dose against T. trichiura | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. | 14-21 days after treatment |
| Cure rate (CR) and egg reduction rate (ERR) of oxantel pamoate multiple doses compared to mebendazole against T. trichiura | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. | 14-21 days after treatment |
| Cure rates (CRs) and egg reduction rates (ERRs) of oxantel pamoate compared to mebendazole against Ascaris lumbricoides and hookworm infections in co-infected participants | CR and ERR will be calculated as described in primary outcome measure and the first listed secondary outcome measure, respectively. | 14-21 days after treatment |
| Number of adverse events (AE) to assess safety and tolerability of oxantel pamoate administered as a single dose or as multiple doses, and compared with mebendazole | Participants will be monitored at the site for 3 hours following treatment for any acute AEs. Participants will be interviewed 3 hours after treatment, as well as 24 hours after every dose received, as well as 14-21days after the last treatment dose 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 (and 48 and 72h for the multiple dose treatment arm) and 14-21 days after treatment |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |