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| Name | Class |
|---|---|
| National Institute of Public Health, Vientiane, Laos | OTHER |
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Efficacy, safety and pharmacokinetics of ascending dosages of emodepside and in comparison to ivermectin against Strongyloidiasis stercoralis in adults: randomized stage II seamless adaptive controlled trials
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emodepside 5 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Emodepside 10 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Emodepside 15 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Emodepside 20 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Emodepside 25 mg | Experimental | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Emodepside 30 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emodepside | Drug | 5 mg tablets of emodepside and matching placebo tablets, 3mg ivermectin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cure rate (CR) of emodepside against Strongyloides stercoralis | The CR will be calculated as the proportion of Strongyloides stercoralis larvae-positive participants at baseline who become larvae-negative after treatment. | In the week between 14 and 21 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of the dose-dependent emodepside treatment regimes, and compared with ivermectin. | AEs will be evaluated descriptively as the difference of proportion reported AEs before and after treatment. | Actively evaluated at 3 hours, 24 hours, 72 hours, and 14 days post-treatment |
| Geometric Mean Larvae Reduction Rate (LRR) of emodepside against Strongyloides stercoralis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lao Tropical and Public Health Institute | Vientiane | Laos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40580974 | Derived | Taylor L, Many S, Jeanguenat H, Hattendorf J, Sayasone S, Keiser J. Efficacy and safety of ascending doses of emodepside in comparison with ivermectin in adults infected with Strongyloides stercoralis in Laos: a phase 2a, dose-ranging, randomised, parallel-group, placebo-controlled, single-blind clinical trial. Lancet Infect Dis. 2025 Nov;25(11):1254-1264. doi: 10.1016/S1473-3099(25)00255-5. Epub 2025 Jun 25. |
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| ID | Term |
|---|---|
| D013322 | Strongyloidiasis |
| ID | Term |
|---|---|
| D017196 | Rhabditida Infections |
| D017190 | Secernentea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
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| ID | Term |
|---|---|
| C468987 | emodepside |
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Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Placebo | Placebo Comparator | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
| Ivermectin 3 mg | Active Comparator | Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or ivermectin (200 μg/kg) or placebo. |
|
The LRRs will be calculated based on the geometric mean |
| In the week between 14 and 21 days post-treatment |
| Exposure response of emodepside in adults | Emodepside will be quantified using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method. Drug concentrations will be calculated by interpolation from a calibration curve with a foreseen limit of quantification of approximately 1-5 ng/ml. | Actively collected at 0 hours, 0.5 hours, 2.5 hours, 5 hours, 24 hours, 72 hours, and 14 days post-treatment |
| Cure rate (CR) and egg reduction rate (ERR) with other soil-transmitted helminths (STH) and trematodes | The CR will be calculated as the proportion of the STH or trematode positive participants at baseline who become egg-negative after treatment. The egg reduction rate (ERR) is calculated as follows: ERR = (1-(geometric mean EPG at follow-up/geometric mean EPG at baseline))*100). | In the week between 14 and 21 days post-treatment |
| D010272 |
| Parasitic Diseases |
| D007239 | Infections |