Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-30 @ 7:42 AM
Study NCT ID:
NCT00755560
Status:
UNKNOWN
Last Update Posted:
2023-03-02
First Post:
2008-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Asymptomatic Toxocariasis With Albendazole in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014120', 'term': 'Toxocariasis'}, {'id': 'D004802', 'term': 'Eosinophilia'}], 'ancestors': [{'id': 'D006374', 'term': 'Helminthiasis, Animal'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017191', 'term': 'Ascaridida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D010273', 'term': 'Parasitic Diseases, Animal'}, {'id': 'D000820', 'term': 'Animal Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-28', 'studyFirstSubmitDate': '2008-09-17', 'studyFirstSubmitQcDate': '2008-09-18', 'lastUpdatePostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean absolute reduction in eosinophil count from baseline', 'timeFrame': '12 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Reduction in eosinophil count in more than 60% from baseline', 'timeFrame': '1 year'}, {'measure': 'Incidence of adverse drug events', 'timeFrame': '3, 6, 9 and 12 months after treatment'}, {'measure': 'Mean absolute reduction in eosinophil count', 'timeFrame': '3, 6, 9 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Toxocara', 'Pediatrics', 'Albendazole', 'eosinophilia', 'parasitology', 'pediatric clinical pharmacology'], 'conditions': ['Toxocariasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate effectiveness of albendazole in the treatment of the asymptomatic infection with the parasite Toxocara in children. Treatment response is defined as a reduction in the number of eosinophils in blood. The study drug will be compared to placebo and randomly assigned in a double blind manner. Follow up will be prospective. 50 children (25 per group) will be enrolled in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric ambulatory patients with asymptomatic toxocariasis\n* Children 2 - 15 years old\n* Absolute eosinophil count \\> 1100 / mm3\n* Normal ophthalmoscopy\n\nExclusion Criteria:\n\n* Treatment with a benzimidazole in the previous year\n* Infection by other nematodes (Ascaris lumbricoides, strongyloides stercoralis, uncinarias, Trichuris trichuria)\n* Symptomatic patients (prolonged fever, acute pneumonitis, hepatomegaly, splenomegaly, ocular compromise due to toxocara)\n* Concomitant diseases\n* Immunocompromised patients\n* Altered liver or kidney function\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00755560', 'briefTitle': 'Treatment of Asymptomatic Toxocariasis With Albendazole in Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Niños R. Gutierrez de Buenos Aires'}, 'officialTitle': 'Treatment of Asymptomatic Toxocariasis With Albendazole in Children. A Prospective, Randomized, Placebo-controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'TOXOCARA-ALBENDAZOLE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Albendazole', 'description': 'Albendazole 10 - 15 mg/kg/day BID for 15 days', 'interventionNames': ['Drug: Albendazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo BID for 15 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Albendazole', 'type': 'DRUG', 'description': 'Albendazole 10 - 15 mg/kg/day BID for 15 days', 'armGroupLabels': ['Albendazole']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo BID for 15 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Parasitology Division, Children\'s Hospital "R Gutierrez" of Buenos Aires', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'overallOfficials': [{'name': 'Jaime Altcheh, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Parasitology Division, Children\'s Hospital "R Gutierrez" of Buenos Aires'}, {'name': 'Hector Freilij, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parasitology Division, Children\'s Hospital "R Gutierrez" of Buenos Aires'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Niños R. Gutierrez de Buenos Aires', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Service Head, Parasitology and Chagas Service', 'investigatorFullName': 'Dr Jaime Altcheh', 'investigatorAffiliation': 'Hospital de Niños R. Gutierrez de Buenos Aires'}}}}