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| Name | Class |
|---|---|
| Public Health Laboratory Ivo de Carneri | OTHER |
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The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emodepside 5 mg | Experimental |
| |
| Emodepside 10 mg | Experimental |
| |
| Emodepside 15 mg | Experimental |
| |
| Emodepside 20 mg | Experimental |
| |
| Emodepside 25 mg | Experimental |
| |
| Emodepside 30 mg | Experimental |
| |
| Albendazole | Active Comparator |
| |
| Placebo | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emodepside | Drug | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of emodepside against Trichuris trichiura | CR will be calculated as the percentage of Trichuris trichiura egg-positive participants at baseline who become egg-negative after treatment. | In the week between 14 and 21 days post-treatment |
| 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 Trichuris trichiura and 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 | 122 | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37195949 | Derived | Montresor A, Gabrielli AF. Emodepside - A Promising Drug for the Treatment of Soil-Transmitted Helminthiases. N Engl J Med. 2023 May 18;388(20):1907-1908. doi: 10.1056/NEJMe2303793. No abstract available. | |
| 37195942 | Derived | Mrimi EC, Welsche S, Ali SM, Hattendorf J, Keiser J. Emodepside for Trichuris trichiura and Hookworm Infection. N Engl J Med. 2023 May 18;388(20):1863-1875. doi: 10.1056/NEJMoa2212825. |
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| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C468987 | emodepside |
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|
| In the week between 14 and 21 days post-treatment |
| CR against Ascaris lumbricoides | CR will be calculated as the percentage of Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment. | In the week between 14 and 21 days post-treatment |
| ERR against Ascaris lumbricoides | 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). | In the week between 14 and 21 days post-treatment |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |