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| Name | Class |
|---|---|
| Centre Suisse de Recherches Scientifiques en Cote d'Ivoire | OTHER |
| Université Félix Houphouët-Boigny | UNKNOWN |
| Bayer | INDUSTRY |
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The purpose of this clinical trial is to compare the efficacy and safety of emodepside with the standard treatment, albendazole, in adolescents (12 years and older) and adults infected with Trichuris incognita.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emodepside 15mg | Experimental |
| |
| Albendazole 400 mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emodepside | Drug | Treatment with 15 mg of emodepside |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of emodepside compared to albendazole against Trichuris incognita | Trichuris incognita infection status of participants 14-21 days post-treatment assessed by Kato-Katz. CRs will be calculated as the percentage of egg-positive participants at screening who become egg-negative after treatment, for each treatment arm. Differences in CRs between the two treatments will be assessed. | Between 14-21 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Egg-reduction rate (ERR) of emodepside compared to albendazole against Trichuris incognita | 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 mean egg counts will be calculated for the different treatment arms before and after treatment to assess the corresponding ERRs. ERR is caluclated as follows: ERR = (1- (geometric mean EPG at follow-up ÷ geometric mean EPG at baseline)) x 100 |
| Measure | Description | Time Frame |
|---|---|---|
| CR and ERR of emodepside and albendazole against Ascaris lumbricoides and hookworm in co-infected participants | If there are enough co-infections in the sample, exploratory analyses will be performed to assess the difference in cure rates and ERR for hookworm and A. lumbricoides. If there are fewer than 30 participants with co-infections of a certain species in total, the results will only be provided descriptively. |
Inclusion Criteria:
Exclusion Criteria:
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| Albendazole 400 mg |
| Drug |
Treatment with 400mg of albendazole |
|
| Between 14-21 days post-treatment |
| Safety and tolerability | Tolerability of treatments (adverse events (AEs)) will be assessed at 3- and 24- hours post-treatment and at 14 - 21 days follow up. The safety analysis will be conducted on all participants who were treated and include all available drug safety data. AEs will be evaluated descriptively as the difference between proportions of reported AEs before and after treatment. | 3- and 24- hours post-treatment and retrospectively 14-21 days post-treatment |
| Between 14-21 days post-treatment |
| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C468987 | emodepside |
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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