Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:44 PM
Study NCT ID:
NCT00373568
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2006-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007896', 'term': 'Leishmaniasis'}], 'ancestors': [{'id': 'D056986', 'term': 'Euglenozoa Infections'}, {'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012876', 'term': 'Skin Diseases, Parasitic'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C039128', 'term': 'miltefosine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2007-12'}, 'lastUpdateSubmitDate': '2010-05-29', 'studyFirstSubmitDate': '2006-09-07', 'studyFirstSubmitQcDate': '2006-09-07', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy'}], 'secondaryOutcomes': [{'measure': 'safety'}]}, 'conditionsModule': {'keywords': ['mucosal', 'miltefosine'], 'conditions': ['Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis', 'detailedDescription': 'Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mucosal leishmaniasis\n\nExclusion Criteria:\n\n* No comcomitant disease as judged by laboratory and clinical parameters'}, 'identificationModule': {'nctId': 'NCT00373568', 'briefTitle': 'Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis', 'organization': {'class': 'OTHER', 'fullName': 'AB Foundation'}, 'officialTitle': 'Miltefosine (42 Days) for Mucosal Leishmaniasisi', 'orgStudyIdInfo': {'id': '05--01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'miltefosine: 2.5 mg/kg/day for 42 days', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Palos Blancos', 'country': 'Bolivia', 'facility': 'Palos Blancos', 'geoPoint': {'lat': -21.41361, 'lon': -63.78165}}], 'overallOfficials': [{'name': 'Jaime Soto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CIBIC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Foundation', 'class': 'OTHER'}}}}