Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT02045069
Status:
UNKNOWN
Last Update Posted:
2015-11-02
First Post:
2014-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ivermectin Against Dengue Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to resolution of viremia', 'timeFrame': 'Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.'}], 'secondaryOutcomes': [{'measure': 'Time to clearance of NS1 antigen', 'timeFrame': 'Every 12 hr, from date of randomization until resolution of viremia or until fever subsides for 1 day, whichever came first.'}, {'measure': 'Time of subsidence of fever', 'timeFrame': 'From date of randomization until fever subsides'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Dengue Fever']}, 'referencesModule': {'references': [{'pmid': '33124646', 'type': 'DERIVED', 'citation': 'Ooi EE. Repurposing Ivermectin as an Anti-dengue Drug. Clin Infect Dis. 2021 May 18;72(10):e594-e595. doi: 10.1093/cid/ciaa1341. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Efficacy and Safety of Ivermectin in Children and Adult patients with Dengue Infection.', 'detailedDescription': 'Patients with confirmed dengue infection who meet all inclusion and exclusion criteria will be enrolled in the study and admitted in the hospital. Patients will be randomly assigned in a pre-specified ratio of 1:1:1 to one of the following study groups: ivermectin 200-400 µg/kg single daily dose for 2 days, ivermectin 200-400 µg/kg single daily dose for 3 days, or placebo. Tablets of ivermectin or placebo will be administered for 3 days. Clinical exam will be performed daily during hospitalization and blood samples will be collected for hematology, clinical chemistry, serology, viral load and quantitative nonstructural 1 (NS1) antigen. Safety assessment will be conducted during admission. Patients will be discharged one day after fever subsidence and will be asked to return 2 weeks after first dose of study medication for safety assessment and blood sampling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ages of 15 or greater.\n* History or presence of fever (temperature \\> 38°C) of ≤ 72 hr duration.\n* Clinical suspicion of dengue infection such as high fever without an evidence or suspected focus of infection on clinical examination.\n* Positive NS 1 strip assay\n\nExclusion Criteria:\n\n* Clinically significant abnormal laboratory results which are deemed to be unassociated with dengue infection\n* Clinical evidence or a history of significant respiratory, metabolic, renal, hepatic, hematologic or chronic diseases\n* History of autoimmune, immune dysfunction disorder or taking warfarin\n* Clinical suspicion of any bacterial infection\n* Pregnancy and lactating women'}, 'identificationModule': {'nctId': 'NCT02045069', 'briefTitle': 'Efficacy and Safety of Ivermectin Against Dengue Infection', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Phase II/III, Randomized, Placebo Controlled Trial of Efficacy and Safety of Ivermectin in Children and Adult Patients With Dengue Infection', 'orgStudyIdInfo': {'id': 'ESIDEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 days Ivermectin', 'description': 'Ivermectin 200 - 400 µg/kg once daily for 2 days', 'interventionNames': ['Drug: 2 days Ivermectin']}, {'type': 'EXPERIMENTAL', 'label': '3 days Ivermectin', 'description': 'Ivermectin 200-400 µg/kg once daily for 3 days', 'interventionNames': ['Drug: 3 days Ivermectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': '2 days Ivermectin', 'type': 'DRUG', 'otherNames': ['Mectizan', 'Ivomec', 'Stromectol'], 'description': '200-400 µg/kg once daily for 2 days and placebo once daily at D3', 'armGroupLabels': ['2 days Ivermectin']}, {'name': '3 days Ivermectin', 'type': 'DRUG', 'description': '200 -400 µg/kg once daily for 3 days', 'armGroupLabels': ['3 days Ivermectin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once daily for 3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nasikarn Angkasekwinai, MD', 'role': 'CONTACT', 'email': 'nasikarn@gmail.com', 'phone': '66818708766'}], 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Yupin Supputamonkol, MD.', 'role': 'CONTACT', 'email': 'ysuputtamongkol@gmail.com', 'phone': '6681-754-5573'}, {'name': 'Panisadee Avirutnan, MD, PhD.', 'role': 'CONTACT', 'email': 'panisadee.avi@mahidol.ac.th', 'phone': '6681-895-0019'}], 'overallOfficials': [{'name': 'Panisadee Avirutnan, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Dengue Hemorrhagic Fever Research Department of Research and Development, Faculty of Medicine Siriraj Hospital Mahidol University, Bangkok 10700, THAILAND'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}