Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 10:31 AM
Study NCT ID:
NCT02281669
Status:
UNKNOWN
Last Update Posted:
2014-11-03
First Post:
2014-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016773', 'term': 'Leishmaniasis, Cutaneous'}], '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': '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': 'D000967', 'term': 'Antimony Sodium Gluconate'}], 'ancestors': [{'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005942', 'term': 'Gluconates'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2014-10-30', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse effects', 'timeFrame': '1 year', 'description': 'The adverse effects of IL Pentostam treatment will be monitored during the follow up period.'}], 'secondaryOutcomes': [{'measure': 'Lesion healing', 'timeFrame': '1 year', 'description': 'Lesions number and size will be recorded and response to treatment will be monitored.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cutaneous Leishmaniasis']}, 'descriptionModule': {'briefSummary': 'Cutaneous leishmaniasis (CL) is endemic in Israel and is caused by Leishmania major or Leishmania tropica. CL is usually a benign disease and limited to the skin. One of the local treatment available is intralesional (IL) Pentostam injection. During the current study the investigators will monitor the adverse effects of this treatment and will follow up the recovery of the lesions after Pentostam injections.', 'detailedDescription': 'Cutaneous leishmaniasis is usually treated by topical intervention. In more severe cases intralesional Pentostam injection may be applied. This treatment is extremely efficient but painful, however without the known adverse effects of IV Pentostam treatment.\n\nIn this study the investigators will follow systematically all leishmania patients who are receiving the intralesional treatment. A structured questionnaire will be filled up in each doctor visit.\n\nThe current study goal is to examine the adverse effects and the patient reaction to this treatment, and to follow the recovery of lesion(s) after this treatment including the number of IL injections which was needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients arriving to the Geographic clinic or to the Skin clinic, diagnosed with Cutaneous leishmaniasis, and the treatment which is choosen by their physican is Pentostam injections.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cutaneous leishmaniasis patients\n* Treatment by IL Pentostam\n* Age above 18 years\n\nExclusion Criteria:\n\n* Children and pregnant women will not participate in the study'}, 'identificationModule': {'nctId': 'NCT02281669', 'briefTitle': 'Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Prospective Observational Study of Intralesional Treatment With Pentostam in Cutaneous Leishmaniasis Israeli Patients', 'orgStudyIdInfo': {'id': 'SHEBA-14-1571-ES-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Research group', 'description': 'The study group includes all CL cases for whom the treating physician decides to treat by IL Pentostam. The patients will return to follow up and additional treatment every 3 weeks until full recovery \\[as our current policy\\].', 'interventionNames': ['Drug: Pentostam']}], 'interventions': [{'name': 'Pentostam', 'type': 'DRUG', 'otherNames': ['Pentavalent antimonials'], 'description': 'Intralesional injection of Pentostam', 'armGroupLabels': ['Research group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Center of Geographic Medicine', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'Eli Schwartz, M.D, DTMH', 'role': 'CONTACT', 'email': 'Eli.schwartz@sheba.health.gov.il', 'phone': '+97235308456'}], 'overallOfficials': [{'name': 'Eli Schwartz, M.D, DTMH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator of the geographic clinic, Sheba medical center', 'investigatorFullName': 'Prof. Eli Schwartz MD, DTMH', 'investigatorAffiliation': 'Sheba Medical Center'}}}}