Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT05538767
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006725', 'term': 'Hookworm Infections'}, {'id': 'D000724', 'term': 'Ancylostomiasis'}], 'ancestors': [{'id': 'D017206', 'term': 'Strongylida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C468987', 'term': 'emodepside'}, {'id': 'D015766', 'term': 'Albendazole'}], 'ancestors': [{'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 320}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-13', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cure rate (CR) of emodepside against hookworm', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'CR will be calculated as the percentage of hookworm egg-positive participants at baseline who become egg-negative after treatment.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Egg Reduction Rate (ERR) of the emodepside against hookworm.', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': '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).'}, {'measure': 'CR of emodepside against Trichuris trichiura and Ascaris lumbricoides', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': 'CR will be calculated as the percentage of Trichuris trichiura and Ascaris lumbricoides egg-positive participants at baseline who become egg-negative after treatment.'}, {'measure': 'ERR of the emodepside against Trichuris trichiura and Ascaris lumbricoides.', 'timeFrame': 'In the week between 14 and 21 days post-treatment', 'description': '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).'}, {'measure': 'Infection status and intensity assessed for at baseline and 14-21 days post-treatment by FECPAK-G2.', 'timeFrame': 'At baseline and 14-21 days post-treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hookworm', 'Emodepside', 'Efficacy', 'Safety', 'Confirmatory Stage', 'Soil Transmitted Helminth'], 'conditions': ['Hookworm Infections']}, 'referencesModule': {'references': [{'pmid': '39153818', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'To compare the efficacy and safety of emodepside to that of albendazole (Zentel®) in participants aged 12-60, inclusive, infected with hookworm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adults aged between 12 and 60 years;\n* Written and signed informed consent;\n* Was examined by a study physician before treatment;\n* Provided two stool samples at baseline;\n* Hookworm EPG \\> 48 and at least two Kato-Katz thick smears slides with more than one hookworm eggs.\n\nExclusion Criteria:\n\n* Pregnant or lactating and/or planning to become pregnant within three months after drug treatment;\n* Type 1 and/or 2 diabetes;\n* Psychiatric disorders;\n* History of ophthalmological conditions;\n* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment;\n* Suffers from severe anaemia (Hb \\< 80 g/l);\n* Received anthelminthic treatment within past four weeks;\n* Attending other clinical trials during the study;\n* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin;\n* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir.\n* Participated in stage I trials of this protocol'}, 'identificationModule': {'nctId': 'NCT05538767', 'briefTitle': 'Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Hookworm', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Tropical & Public Health Institute'}, 'officialTitle': 'Efficacy and Safety of Emodepside in Adolescents and Adults Infected With Trichuris Trichiura and Hookworm: Randomized Two Stages Phase II Seamless Adaptive Controlled Single-blind Trials', 'orgStudyIdInfo': {'id': 'EMODEPSIDE_PEMBA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emodepside 30 mg', 'interventionNames': ['Drug: Emodepside']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Albendazole 400 mg', 'interventionNames': ['Drug: Albendazole 400mg']}], 'interventions': [{'name': 'Emodepside', 'type': 'DRUG', 'description': 'Treatment with Emodepside 30 mg', 'armGroupLabels': ['Emodepside 30 mg']}, {'name': 'Albendazole 400mg', 'type': 'DRUG', 'description': 'Treatment with Albendazole 400 mg', 'armGroupLabels': ['Albendazole 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '122', 'city': 'Chake Chake', 'state': 'Pemba', 'country': 'Tanzania', 'facility': 'Public Health Laboratory Ivo de Carneri', 'geoPoint': {'lat': -5.24586, 'lon': 39.76659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jennifer Keiser', 'class': 'OTHER'}, 'collaborators': [{'name': 'Public Health Laboratory Ivo de Carneri', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Jennifer Keiser', 'investigatorAffiliation': 'Swiss Tropical & Public Health Institute'}}}}