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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| Silicon Valley Community Foundation | OTHER |
| University of the Philippines | OTHER |
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This study aims to assess the efficacy and safety of emodepside compared to mebendazole in adults and adolescents infected with T. trichiura, either as single infection or co-infections with hookworm and/or A. lumbricoides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emodepside | Experimental |
| |
| Mebendazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emodepside (BAY 44-4400) | Drug | Treatment with single dose of oral 15 mg emodepside |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cured of T. trichiura infection | Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit | Test of Cure Visit at 14 to 21 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cured of A. lumbricoides infection | Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit. This endpoint is only applicable for the subgroup of participants co-infected with A. lumbricoides at baseline. | Time Frame: Test of Cure Visit at 14 to 21 days after end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Cured of hookworm infection | Determined by negative Kato-Katz thick smears in two stool samples taken at the Test of Cure Visit. This endpoint is only applicable for the subgroup of participants co-infected with hookworm at baseline. | Test of Cure Visit at 14 to 21 days after end of treatment |
| Egg reduction of each species of STH (T. trichiura, A. lumbricoides and hookworm infection) |
Inclusion Criteria:
Exclusion Criteria:
Presence of any systemic illnesses, renal and/or hepatic impairment, any other acute or chronic health conditions or congenital disorders which, in the opinion of the Investigator, would make the participant unsuitable for participation in a clinical study or may interfere with the efficacy, safety, and/or pharmacokinetic (PK) evaluation of the study drug.
Any of the following:
Treatment with the following anthelminthic drugs: albendazole, mebendazole, ivermectin, within 28 days before the first dose of study intervention or planned before End of Study Visit.
Use of sensitive CYP3A4 substrates within 14 days before the start of the first study intervention and until at least 14 days after the last administration of study intervention.
Treatment with metronidazole within 2 days before the first dose of study intervention or planned before 24 hours after last administration of study intervention.
Previous assignment to a study intervention for another study planned to be administered during the period the participant is enrolled in this study (from date of informed consent to last follow-up).
Known allergy/hypersensitivity to mebendazole and/or emodepside
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Keiser, Professor | Contact | +41 61 284 82 18 | jennifer.keiser@swisstph.ch |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Keiser, Professor | Swiss Tropical & Public Health Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siargao Island Medical Center | Dapa | Philippines |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37195942 | Background | 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. | |
| 39153818 | Background | 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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There is a data sharing agreement between Swiss TPH and PHL-IdC in place (study site). Data may be shared with other researchers upon request.
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Sponsor staff, Site staff
| Mebendazole 100 MG |
| Drug |
Treatment with 100 mg mebendazole orally administered b.i.d. for 3 days |
|
| similar placebo to mebendazole | Drug | Treatment with mebendazole similar placebo orally administered b.i.d. for 3 days |
|
| matching placebo of emodepside | Drug | Treatment with single dose of oral emodepside matching placebo |
|
| Occurrence of TEAEs |
Defined as any AE that occurred or worsened after the first dose of study intervention up to 21 days after the last dose of study intervention |
| Adverse events that occur after the first dose of study intervention up to 21 days after the last dose of study intervention |
Defined as logarithm of the number of eggs/g (+1) from stool samples taken at the Test of Cure Visit minus the logarithm of the number of eggs/g (+1) in stool samples taken at baseline. Egg reduction of A. lumbricoides and hookworm will only be calculated in participants co-infected with A. lumbricoides and hookworm at baseline, respectively. |
| Test of Cure Visit at 14 to 21 days after end of treatment |
| Listing of individual plasma concentrations of emodepside | Plasma concentrations at 3, 6, 21-48 hours and 14-21 days after the end of treatment |
| ID | Term |
|---|---|
| D014257 | Trichuriasis |
| D006725 | Hookworm Infections |
| D000724 | Ancylostomiasis |
| D017229 | Enterobiasis |
| ID | Term |
|---|---|
| D017189 | Enoplida Infections |
| D017188 | Adenophorea Infections |
| D009349 | Nematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D017206 | Strongylida Infections |
| D017190 | Secernentea Infections |
| D010123 | Oxyuriasis |
| D017194 | Oxyurida Infections |
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| ID | Term |
|---|---|
| C468987 | emodepside |
| C439266 | Bay 44-4400 |
| D008463 | Mebendazole |
| 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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