Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-26 @ 7:42 AM
Study NCT ID:
NCT01570504
Status:
COMPLETED
Last Update Posted:
2018-06-14
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Peru']}, 'conditionBrowseModule': {'meshes': [{'id': 'D013322', 'term': 'Strongyloidiasis'}], 'ancestors': [{'id': 'D017196', 'term': 'Rhabditida 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': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-04-02', 'lastUpdatePostDateStruct': {'date': '2018-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clearance of strongyloides infection', 'timeFrame': '12 months', 'description': 'Clearance of infection is defined by: negative stool agar/charcoal culture/RT-PCR - direct examination of three faecal samples for S. stercoralis AND negative serology or decrease in titer below a defined cutoff'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality during the 12 months of follow-up.', 'timeFrame': '12 months'}, {'measure': 'Patients with partial response to treatment at T 2', 'timeFrame': '12 months'}, {'measure': 'Patients with adverse reactions', 'timeFrame': 'From Day 1st to Day 5th of treatment and from Day 15th to Day 19th (or 72 hours from treatment completion)', 'description': 'grade 1 to 5 as defined in detailed protocol'}, {'measure': 'Patients with increase in blood ALT over cutoff value', 'timeFrame': 'Day 17'}, {'measure': 'Patients with decrease in WBC count below cutoff value', 'timeFrame': 'Day 17'}, {'measure': 'Average difference in blood ALT and WBC count at day 17, compared with baseline', 'timeFrame': 'Day 17'}, {'measure': 'Average difference in blood eosinophil count at T2, compared with baseline', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Strongyloidiasis', 'Strongyloides stercoralis', 'Ivermectin'], 'conditions': ['Strongyloidiasis']}, 'referencesModule': {'references': [{'pmid': '31558376', 'type': 'DERIVED', 'citation': 'Buonfrate D, Salas-Coronas J, Munoz J, Maruri BT, Rodari P, Castelli F, Zammarchi L, Bianchi L, Gobbi F, Cabezas-Fernandez T, Requena-Mendez A, Godbole G, Silva R, Romero M, Chiodini PL, Bisoffi Z. Multiple-dose versus single-dose ivermectin for Strongyloides stercoralis infection (Strong Treat 1 to 4): a multicentre, open-label, phase 3, randomised controlled superiority trial. Lancet Infect Dis. 2019 Nov;19(11):1181-1190. doi: 10.1016/S1473-3099(19)30289-0. Epub 2019 Sep 23.'}]}, 'descriptionModule': {'briefSummary': 'Ivermectin is currently the best drug to cure strongyloidiasis, but the "standard" single dose of 200 mcg/kg is probably not enough to guarantee cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite.\n\nAim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients older than 5 years and weighting \\> 15 kg\n* Current residence in non-endemic areas\n* Either direct diagnosis of S. stercoralis infection AND positive serology at any titer OR positive serology at "high" titer, irrespective of results of direct tests\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Subjects suffering from CNS diseases\n* Disseminated strongyloidiasis\n* Immunocompromised patients.\n* Lack of informed consent\n* Previous treatment with ivermectin (in the last year)'}, 'identificationModule': {'nctId': 'NCT01570504', 'acronym': 'STRONGTREAT', 'briefTitle': 'Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Centro per le Malattie Tropicali'}, 'officialTitle': 'Randomized, Open-label, Multi Centre Phase III Clinical Trial on Multiple Versus Single Dose of Ivermectin for the Treatment of Strongyloidiasis', 'orgStudyIdInfo': {'id': 'CTD1-2012'}, 'secondaryIdInfos': [{'id': '2011-002784-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ivermectin multiple doses', 'description': 'A dose of 200 mcg/kg of ivermectin given on days 1,2, 15 and 16', 'interventionNames': ['Drug: Ivermectin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 dose ivermectin', 'description': 'A single 200 mcg/kg dose of ivermectin', 'interventionNames': ['Drug: Ivermectin']}], 'interventions': [{'name': 'Ivermectin', 'type': 'DRUG', 'otherNames': ['Stromectol'], 'description': 'oral formulation', 'armGroupLabels': ['1 dose ivermectin', 'ivermectin multiple doses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'country': 'Italy', 'facility': 'Centro per le Malattie Tropicali, Ospedale Sacro Cuore', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}, {'city': 'Brescia', 'country': 'Italy', 'facility': 'Clinica di Malattie Infettive e Tropicali', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'UFDID, Azienda Ospedaliero-universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Florence', 'country': 'Italy', 'facility': "Unità di Malattie Infettive, Anna Meyer Children's Universisty Hospital", 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'El Ejido', 'state': 'Almeria', 'country': 'Spain', 'facility': 'Unidad de Medicina, Hospital de Poniente-El Ejido', 'geoPoint': {'lat': 36.77629, 'lon': -2.81456}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'FCRB, Hospital Clinic de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Unitat Medicina Tropical i Salut Internacional Drassanes', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Addenbrookes Hospital, Cambridge University Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'UCLH', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Zeno Bisoffi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Tropical Diseases, Negrar (Verona), Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro per le Malattie Tropicali', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}