Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 12:53 PM
Study NCT ID:
NCT01308268
Status:
UNKNOWN
Last Update Posted:
2011-03-04
First Post:
2011-03-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Soil-transmitted Helminthiasis and Strongyloidiasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006373', 'term': 'Helminthiasis'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007559', 'term': 'Ivermectin'}, {'id': 'D015766', 'term': 'Albendazole'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-03-03', 'studyFirstSubmitDate': '2011-03-03', 'studyFirstSubmitQcDate': '2011-03-03', 'lastUpdatePostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of local epidemiology of soil-transmitted helminthiases and impact of a mass drug treatment anti-helminthic strategy', 'timeFrame': '15 months', 'description': 'Evaluate local epidemiology of STH: frequency of species, prevalence and intensity of infections, groups more affected, morbidity.\n\nEvaluate the efficacy of a single-dose anti-helminthic regimen for community treatments: albendazole 400 mg + ivermectin 200 mcg/kg.'}], 'secondaryOutcomes': [{'measure': 'Validate serology methods for diagnosis of S. stercoralis infection', 'timeFrame': '15 months', 'description': 'Compare sensibility, specificity and predictive values of serology for S.stercoralis (ELISA-NIE) with traditional coproparasitological methods'}, {'measure': 'Assess the tolerability and safety of the combination of ivermectin and albendazole', 'timeFrame': '15 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['STH', 'Soil-transmitted Helminthiasis', 'mass drug administration'], 'conditions': ['Helminthiasis', 'Strongyloides Stercoralis Infection']}, 'descriptionModule': {'briefSummary': 'The general purpose of the project is to analyse soil-transmitted helminthiases (STH) in a highly endemic area in northern Argentina with a multidisciplinary approach. The specific objectives are to evaluate the local epidemiology of STH, validate a new diagnostic serology method for S. stercoralis and evaluate the efficacy and safety of a mass drug administration regimen with albendazole and ivermectin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All persons that are living in the working area at the time of the intervention and wish to participate in the study.\n\nExclusion Criteria:\n\n1. All persons that live within the study area but do not want to participate in the study.\n2. Pregnant women or women who are likely pregnant.\n3. Women during the first post-partum week if they are breastfeeding.\n4. Children who weigh less than 15 kg.\n5. Persons with a history of hypersensitivity or intolerance to ivermectin, albendazole or to the components that make up those drugs.'}, 'identificationModule': {'nctId': 'NCT01308268', 'briefTitle': 'Management of Soil-transmitted Helminthiasis and Strongyloidiasis', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Nacional de Salta'}, 'officialTitle': 'Community-based Approach for the Management of Soil-transmitted Helminthiasis in General and Strongyloidiasis in Particular in a Highly Endemic Area', 'orgStudyIdInfo': {'id': 'IIET-05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ivermectin + Albendazole', 'type': 'DRUG', 'description': 'Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (\\>= 2 years old) single dose, PO'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4530', 'city': 'Orán', 'state': 'Salta Province', 'status': 'RECRUITING', 'country': 'Argentina', 'facility': 'Instituto de Investigación en Enfermedades Tropicales, Universidad Nacional de Salta', 'geoPoint': {'lat': -23.13705, 'lon': -64.32426}}], 'centralContacts': [{'name': 'Alejandro Krolewiecki, MD, PhD', 'role': 'CONTACT', 'email': 'alekrol@hotmail.com', 'phone': '+54-11-45531369'}, {'name': 'María E Socías, MD', 'role': 'CONTACT', 'email': 'eugenia_socias@yahoo.com.ar', 'phone': '+54-11-4803-2298'}], 'overallOfficials': [{'name': 'Alejandro Krolewiecki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Nacional de Salta, Instituto de Investigación en Enfermedades Tropicales'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Nacional de Salta', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación Mundo Sano', 'class': 'UNKNOWN'}, {'name': 'Albert B. Sabin Vaccine Institute', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Alejandro Krolewiecki', 'oldOrganization': 'Instituto de Investigaciones en Enfermedades Tropicales-Universidad Nacional de Salta'}}}}