Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 7:52 AM
Study NCT ID:
NCT00138359
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Treatment T Solium Community Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007411', 'term': 'Intestinal Diseases, Parasitic'}, {'id': 'D002590', 'term': 'Cestode Infections'}, {'id': 'D013622', 'term': 'Taeniasis'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006373', 'term': 'Helminthiasis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009534', 'term': 'Niclosamide'}], 'ancestors': [{'id': 'D012458', 'term': 'Salicylanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 4200}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-12', 'completionDateStruct': {'date': '2005-01'}, 'lastUpdateSubmitDate': '2010-08-26', 'studyFirstSubmitDate': '2005-08-26', 'studyFirstSubmitQcDate': '2005-08-26', 'lastUpdatePostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-08-30', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['T solium, cysticercus, pig triquina, solitaria, intestinal parasites, Niclosamide, tapeworms, Taeniasis'], 'conditions': ['Intestinal Parasitism']}, 'descriptionModule': {'briefSummary': 'Investigators from Cayetano Heredia University and Johns Hopkins University are doing this study. They want to see how people and pigs get infected with a parasite, called cysticercus (known as "pig triquina"). Cysticercus attacks the meat of pigs and the brains of people. In the intestine, the parasite is known as "solitaria". This study is to see how treatment in both people and pigs works to control the disease.', 'detailedDescription': 'This is a prospective intervention study to determine the efficacy and persistence of effect over time of a single, chemotherapy intervention in both the human and porcine population. Four villages will be selected to be treated against T solium adult (in humans) and larval forms (in pigs), and two villages will receive no intervention and will serve as control villages. Pigs in control villages will be followed during 3 months only, and then the human and porcine populations will receive the intervention treatment. The effect of this intervention will be measured by the prevalence of infection in pigs and parasitic burden of infected pigs at month 3, 6, 9, and 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consenting individuals older than two years living in the study villages (6 endemic communities of the Northern coast of Peru)\n\nExclusion Criteria:\n\n* Pregnancy (for antiparasitic treatment only).'}, 'identificationModule': {'nctId': 'NCT00138359', 'briefTitle': 'Mass Treatment T Solium Community Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'The Effect of a Single Control Intervention in the T Solium Life Cycle', 'orgStudyIdInfo': {'id': '04-043'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Niclosamide', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lima', 'country': 'Peru', 'facility': 'Universidad Peruana Cayetano Heredia', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}}}}