Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01162967
Status:
COMPLETED
Last Update Posted:
2013-09-10
First Post:
2010-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014355', 'term': 'Chagas Disease'}], 'ancestors': [{'id': 'D014352', 'term': 'Trypanosomiasis'}, {'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C009999', 'term': 'benzonidazole'}, {'id': 'C101425', 'term': 'posaconazole'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-09', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-07-14', 'lastUpdatePostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parasitological cure measured by a real time PCR in blood sample', 'timeFrame': '12 months after starting treatment', 'description': 'PCR negative at the end of follow up'}], 'secondaryOutcomes': [{'measure': 'Parasitological cure measured by real time PCR in blood sample', 'timeFrame': 'End of treatment, weeks 8, 16, 24 and 40 after treatment', 'description': 'substained parasitological response'}, {'measure': 'Safety and tolerability of both drugs', 'timeFrame': 'First 2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chagas Disease']}, 'referencesModule': {'references': [{'pmid': '24827034', 'type': 'DERIVED', 'citation': "Molina I, Gomez i Prat J, Salvador F, Trevino B, Sulleiro E, Serre N, Pou D, Roure S, Cabezos J, Valerio L, Blanco-Grau A, Sanchez-Montalva A, Vidal X, Pahissa A. Randomized trial of posaconazole and benznidazole for chronic Chagas' disease. N Engl J Med. 2014 May 15;370(20):1899-908. doi: 10.1056/NEJMoa1313122."}]}, 'descriptionModule': {'briefSummary': 'The investigators propose the evaluation of posaconazole and benznidazole in humans for the treatment of Chagas disease chronical infection. Exploratory trial of posaconazole antiparasitic activity against Trypanosoma cruzi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting patients with serological evidence of Chagas infection and positive PCR real time\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01162967', 'acronym': 'CHAGASAZOL', 'briefTitle': 'Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'PROTOCOL FOR PHASE II CLINICAL TRIAL, RANDOMIZED AND OPEN FOR ETIOLOGICAL TREATMENT OF CHRONIC CHAGAS DISEASE WITH POSACONAZOLE AND BENZNIDAZOLE', 'orgStudyIdInfo': {'id': 'CHAGASAZOL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Benznidazole', 'interventionNames': ['Drug: Benznidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Posaconazole, low dose', 'interventionNames': ['Drug: Posaconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Posaconazole, high dose', 'interventionNames': ['Drug: Posaconazole']}], 'interventions': [{'name': 'Benznidazole', 'type': 'DRUG', 'description': 'Standard dosage', 'armGroupLabels': ['Benznidazole']}, {'name': 'Posaconazole', 'type': 'DRUG', 'armGroupLabels': ['Posaconazole, high dose', 'Posaconazole, low dose']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santa Coloma', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'International Health Unit Metropolitana Nord', 'geoPoint': {'lat': 42.36717, 'lon': -2.65598}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Infectious Disease Department Vall d'Hebron Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'International Health Unit Drassanes', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Molina Israel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Infectious Disease Department Vall d'Hebron Hospital"}, {'name': 'Pahisssa Albert, MD Ph', 'role': 'STUDY_CHAIR', 'affiliation': "Infectious Disease Department Vall d'Hebron Hospital"}, {'name': 'Gomez Jordi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Health Unit Drassanes'}, {'name': 'Valerio Lluis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Health Unit Metropolitana Nord'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': "Hospital Vall d'Hebron", 'class': 'OTHER'}, {'name': 'Tropical Medicine and International Health Unit Drassanes. Barcelona', 'class': 'UNKNOWN'}, {'name': 'International Health Unit Metropolitana Nord. Santa Coloma.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}