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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emodepside 30 mg | Experimental |
| |
| Albendazole 400 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emodepside | Drug | Treatment with Emodepside 30 mg |
| |
| Albendazole 400mg |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of emodepside against hookworm | CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment. | In the week between 14 and 21 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm. | 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. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health Laboratory Ivo de Carneri | Chake Chake | Pemba | 122 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39153818 | Derived | Taylor L, Ahmada AA, Ali MS, Ali SM, Hattendorf J, Mohammed IS, Keiser J. Efficacy and safety of emodepside compared with albendazole in adolescents and adults with hookworm infection in Pemba Island, Tanzania: a double-blind, superiority, phase 2b, randomised controlled trial. Lancet. 2024 Aug 17;404(10453):683-691. doi: 10.1016/S0140-6736(24)01403-X. |
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| ID | Term |
|---|---|
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C468987 | emodepside |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Treatment with Albendazole 400 mg |
|
| In the week between 14 and 21 days post-treatment |
| CR of emodepside against Trichuris trichiura and Ascaris lumbricoides | CR will be calculated as the percentage of Trichuris trichiura and Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment. | In the week between 14 and 21 days post-treatment |
| ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides. | 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. The ERR is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). Note: in contrast to the publication the "outcome measure" entry mask requires the complementary percentage: (geometric mean at follow-up/geometric mean at baseline)*100). | In the week between 14 and 21 days post-treatment |
| Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2. | At baseline and 14-21 days post-treatment |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |