[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leishmaniasis-mucocutaneous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leishmaniasis-mucocutaneous":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100631751","leish-ped-study-on-leishmaniasis-in-children-100631751",false,"NCT07504757","LEISH-PED: Study on Leishmaniasis in Children","A Multicenter Study on Leishmaniasis in Children: Clinical and Epidemiological Characteristics and Outcomes","LEISH-PED","Inclusion Criteria:\n\n* Patients younger than 18 years of age at the time of diagnosis\n* Diagnosis of human leishmaniasis according to World Health Organization (WHO) criteria\n* Written informed consent signed by parents or legal guardians; patient assent when applicable\n\nExclusion Criteria:\n\n* Patients who do not meet the diagnostic criteria for confirmed human leishmaniasis\n* Lack of informed consent signed by parents or legal guardians, when required","ALL","17 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","Leishmaniasis is an infection caused by Leishmania parasites. In children, it can affect the skin or internal organs. Diagnosis may be delayed because the signs and symptoms can be similar to those of other conditions. Delayed diagnosis or treatment may lead to worse outcomes. Treatment approaches, especially for cutaneous leishmaniasis, may also vary across centers. This study aims to improve knowledge about pediatric leishmaniasis in Italy.\n\nThis is a multicenter observational study in children younger than 18 years of age with a diagnosis of human leishmaniasis according to World Health Organization criteria. The study includes both retrospective and prospective data from participating centers in Italy. Researchers will collect and analyze clinical, diagnostic, epidemiological, treatment, and outcome data from the baseline visit and from follow-up during the first year.\n\nThe main goal of the study is to describe the clinical and epidemiological features of pediatric leishmaniasis in Italy over the study period, with a particular focus on diagnostic and treatment delay and on patient outcomes. The study will also assess the frequency and severity of disease over time and compare outcomes associated with different treatment approaches, particularly in cutaneous leishmaniasis. Patients evaluated between January 1, 2013 and June 30, 2031 may be included.",[25,26,27,28],"Leishmania Infantum Disease","Leishmaniasis, Visceral","Leishmaniasis, Cutaneous","Leishmaniasis, Mucocutaneous",[30,31,32,33,34,35,36,37],"Pediatric leishmaniasis","Visceral leishmaniasis","Cutaneous leishmaniasis","Mucocutaneous leishmaniasis","Children","Italy","Diagnostic delay","Leishmania infantum","RECRUITING","2026-03-26",{"date":41,"type":42},"2026-04-01","ACTUAL",{"date":44,"type":42},"2025-01-30",{"date":46,"type":21},"2031-12-30",{"name":48,"class":49},"Meyer Children's Hospital IRCCS","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":50},"100519203","phase-2-pilot-study-oral-treatment-of-american-tegumentary-leishmaniasis-cutaneous-and-mucosal-forms-in-the-elderly-100519203","NCT06040489","Pilot Study: Oral Treatment of American Tegumentary Leishmaniasis (Cutaneous and Mucosal Forms) in the Elderly","Inclusion Criteria:\n\n* Active confirmed cutaneous leishmaniasis ou mucosal leishmaniasis\n* Use of highly effective contraceptive method and a negative serologic pregnancy test (beta - HCG), if female in fertile phase\n* Agree and sing informed consent form\n\nExclusion Criteria:\n\n* Previous treatment with leishmanicidal drugs in the last 6 months\n* Pre-treatment electrocardiographic changes that contraindicate the use of liposomal amphotericin B (QTc greater than 450ms)\n* Serum creatinine or urea 1.5 times the upper limit of normal\n* Patients with severe or decompensated liver, kidney, heart disease, Diabetes Mellitus\n* history of any hypersensitivity reaction to liposomal amphotericin B, miltefosine and\u002For pentoxifylline\n* Pregnant and breastfeeding women\n* Patients with Acquired Immunodeficiency Syndrome (AIDS) or other immunodeficiency","50 Years",{"count":59,"type":21},100,"INTERVENTIONAL",[62,63],"PHASE2","PHASE3","Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis",[66,28],"Leishmaniasis; Brazilian",[68,69,70,71,72,73],"Elderly","Miltefosine","Leishmaniasis","Pentoxifylline","Liposomal amphotericin b","Treatment","2023-09-13",{"date":76,"type":42},"2023-09-15",{"date":78,"type":42},"2022-06-22",{"date":80,"type":21},"2026-06",{"name":82,"class":49},"University of Brasilia"]