Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-25 @ 2:06 PM
Study NCT ID:
NCT00378495
Status:
TERMINATED
Last Update Posted:
2016-07-12
First Post:
2006-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Miltefosine for Brazilian Visceral Leishmaniasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007898', 'term': 'Leishmaniasis, Visceral'}], 'ancestors': [{'id': 'D007896', 'term': 'Leishmaniasis'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'whyStopped': 'accrual criteria being reviewed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2006-09-18', 'studyFirstSubmitQcDate': '2006-09-18', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cure rate at 6 months'}], 'secondaryOutcomes': [{'measure': 'cure rate at 1 month'}, {'measure': 'safety'}]}, 'conditionsModule': {'keywords': ['miltefosine', 'kala azar', 'Brazil'], 'conditions': ['Kala Azar']}, 'descriptionModule': {'briefSummary': 'Miltefosine will be administered to Brazilian patients with kala azar', 'detailedDescription': 'Miltefosine will be administered to Brazilian patients with kala azar. Both pediatric and adult patients will be studied. Patients will be followed for 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed (untreated) visceral leishmaniasis with symptomatic disease and visualization of amastigotes in tissue samples or a positive culture.\n\n * Age: Group 1: 2 to 12 years; Group 2: 13 to 60 years\n * Sex: male and female patients eligible (no effort to be made to balance the study for gender)\n\nExclusion Criteria:\n\nExclusion criteria\n\nSafety concerns:\n\n* Thrombocyte count \\<30 x 109/l;\n* Leukocyte count \\<1 x 109/l;\n* Hemoglobin \\<5 g/100 ml;\n* ASAT, ALAT, AP \\>3 times upper limit of normal range;\n* Serum creatinine or BUN \\>1.5 times upper limit of normal range;\n* Evidence of serious underlying disease (cardiac, renal, hepatic or pulmonary);\n* Immunodeficiency or antibody to HIV;\n* Severe protein and/or caloric malnutrition (Kwashiorkor, Marasmus);\n* Any non-compensated or uncontrolled condition;\n* Lactation, pregnancy (to be determined by adequate test) or inadequate contraception in females of childbearing potential for treatment period plus 2 months.\n\nLack of suitability for the trial:\n\n* Negative bone marrow aspirate (smear);\n* Any history of prior anti-leishmania therapy;\n* Any condition which compromises ability to comply with the study procedures;\n* Concomitant serious infection other than visceral leishmaniasis (this would include evidence of other conditions associated with splenomegaly such as schistosomiasis or malaria).\n\nAdministrative reasons:\n\n* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative);\n* Anticipated non-availability for study visits/procedures.'}, 'identificationModule': {'nctId': 'NCT00378495', 'briefTitle': 'Miltefosine for Brazilian Visceral Leishmaniasis', 'organization': {'class': 'OTHER', 'fullName': 'AB Foundation'}, 'orgStudyIdInfo': {'id': 'D-18506-Z019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Miltefosine: initially 2.5 mg/kg/day for 28 days', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Montes Claros', 'country': 'Brazil', 'facility': 'Universidade Estadual de Montes Claros', 'geoPoint': {'lat': -16.735, 'lon': -43.86167}}], 'overallOfficials': [{'name': 'Reynaldo Dietze', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Núcleo de Doenças Infecciosas - UFES'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AB Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'AEterna Zentaris', 'class': 'INDUSTRY'}]}}}