Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT00818818
Status:
COMPLETED
Last Update Posted:
2010-10-08
First Post:
2009-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007896', 'term': 'Leishmaniasis'}, {'id': 'D016773', 'term': 'Leishmaniasis, Cutaneous'}], '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': 'D000077485', 'term': 'Meglumine Antimoniate'}], 'ancestors': [{'id': 'D008536', 'term': 'Meglumine'}, {'id': 'D013012', 'term': 'Sorbitol'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006595', 'term': 'Hexosamines'}, {'id': 'D000606', 'term': 'Amino Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-07', 'studyFirstSubmitDate': '2009-01-06', 'studyFirstSubmitQcDate': '2009-01-06', 'lastUpdatePostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical cure', 'timeFrame': 'Three months after treatment', 'description': 'Clinical cure defined as the complete epithelialization of the ulcerated lesions without any inflamatory sign (erythema, edema, disquamation)'}], 'secondaryOutcomes': [{'measure': 'Adverse events rate - day 7', 'timeFrame': '7th day', 'description': 'Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the first week of treatment'}, {'measure': 'Adverse events rate - day 14', 'timeFrame': '14th day', 'description': 'Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the second week of treatment'}, {'measure': 'Total Adverse events rate', 'timeFrame': '20th day', 'description': 'Biochemical abnormalities detected in serum samples for: SGOT, SGPT, amilase, creatinin, ureia and glycemia, or any sign or symptom experienced during the whole treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Leishmaniasis', 'Cutaneous leishmaniasis', 'Leishmania braziliensis', 'Pentavalent antimonial', 'Glucantime'], 'conditions': ['Localized Cutaneous Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the effect of low doses of pentavalent antimony (meglumine antimoniate) to treat cutaneous leishmaniasis ulcers in patients older than 65 years. The hypothesis is that older patients may have a positive response with a lower dose of pentavalent antimony, avoiding the frequent adverse events observed with the standard dose. The design is that of an open uncontrolled trial enrolling 20 patients infected with the parasite Leishmania braziliensis in an endemic area of the State of Bahia, Brazil. The endpoint of cure or therapeutic failure will be evaluated at the third month of follow-up after treatment to avoid the impact of spontaneous cure as a confounding factor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 65 years\n* Permanent residence in the endemic area\n* Availability of a caregiver for dependent patients\n\nExclusion Criteria:\n\n* Mucosal disease caused by leishmaniasis\n* Disseminated cutaneous disease\n* Severe cardiac, renal or hepatic disorders\n* Active cancer\n* Active tuberculosis\n* Leprosy\n* HIV positive\n* Total bilirubin \\> 1.5mg/dL\n* Urea and creatinin \\> 1.5 times the upper normal level\n* Alkaline phosphatase and aminotransferases \\> 2.5 times the upper normal level\n* Lipase and amylase \\> 1.5 the upper normal level\n* Hemoglobin \\< 5 g/dL of'}, 'identificationModule': {'nctId': 'NCT00818818', 'acronym': 'Sbold', 'briefTitle': 'Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Brasilia'}, 'officialTitle': 'Low-dose Pentavalent Antimony Treatment of Cutaneous Leishmaniasis in Old Age Patients Infected With Leishmania (Viannia) Braziliensis in Bahia State, Brazil. An Open Uncontrolled Trial.', 'orgStudyIdInfo': {'id': 'lowdoseaging'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meglumine antimoniate', 'description': 'Treated with 5mg/kg/d of pentavalent antimony (meglumine antimoniate) intravenously for 20 consecutive days.', 'interventionNames': ['Drug: Meglumine antimoniate']}], 'interventions': [{'name': 'Meglumine antimoniate', 'type': 'DRUG', 'otherNames': ['Glucantime'], 'description': '5mg/kg/d of pentavalent antimony, IV, for 20 consecutive days', 'armGroupLabels': ['Meglumine antimoniate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45416 - 000', 'city': 'Corte de Pedra, Presidente Tancredo Neves', 'state': 'Bahia State', 'country': 'Brazil', 'facility': 'Health Center Unit of Corte de Pedra'}], 'overallOfficials': [{'name': 'Julia S Ampuero-Vela, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, University of Brasilia'}, {'name': 'Gustavo Adolfo S Romero, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, University of Brasilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Brasilia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Gustavo Adolfo Sierra Romero', 'oldOrganization': 'Faculty of Medicine, University of Brasilia'}}}}