[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519203":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":43,"overallOfficials":18,"centralContacts":57,"locations":66,"responsibleParty":83,"collaborators":18,"id":85,"slug":18,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":18,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":91,"maxAge":18,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":69,"whyStopped":18,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Brasilia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Cure","Complete healing of all lesions (cicatrization of ulcers and complete regression of erythema or infiltration)","90 days after the begin of treatment",[14],{"measure":15,"description":16,"timeFrame":17},"Adverse effects","Presence laboratorial or clinica changes during treatment that lead to treatment interruption","30 days after drug interruption",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26,32,35,40],{"label":27,"type":28,"description":18,"interventionNames":29},"Oral Miltefosine and Pentoxifylline for Cutaneous Leishmaniasis","EXPERIMENTAL",[30,31],"Drug: Miltefosine 50mg","Drug: Pentoxifylline 400mg",{"label":33,"type":28,"description":18,"interventionNames":34},"Oral Miltefosine and Pentoxifylline for Mucous Leishmaniasis",[30,31],{"label":36,"type":37,"description":18,"interventionNames":38},"Intravenous Liposomal Amphotericin B for Cutaneous Leishmaniasis","ACTIVE_COMPARATOR",[39],"Drug: Liposomal Amphotericin B",{"label":41,"type":37,"description":18,"interventionNames":42},"Intravenous Liposomal Amphotericin B for Mucous Leishmaniasis",[39],[44,49,53],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":18},"DRUG","Miltefosine 50mg","Oral Miltefosine 50mg bid",[27,33],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":18},"Pentoxifylline 400mg","Oral Pentoxifylline 400mg tid",[27,33],{"type":45,"name":54,"description":55,"armGroupLabels":56,"otherNames":18},"Liposomal Amphotericin B","Intravenous 25 to 40mg\u002Fkg",[36,41],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":18,"email":62},"Raimunda Sampaio, PhD","CONTACT","+556120285415","rnrsampaio@hotmail.com",{"name":64,"role":60,"phone":61,"phoneExt":18,"email":65},"Sofia Martins, PhD","sofiasalesm@gmail.com",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Hospital Universitario de Brasilia","RECRUITING","Brasília","Federal District","70840-901","Brazil","BR",{"type":76,"coordinates":77},"Point",[78,79],-47.92972,-15.77972,{"lat":79,"lon":78},[82],{"name":59,"role":60,"phone":61,"phoneExt":18,"email":62},{"type":84,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100519203",false,"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","ALL","50 Years",{"count":93,"type":94},100,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE2","PHASE3","Randomised clinical trial comparing oral miltefosine associated with pentoxifylline to intravenous liposomal amphotericin b for the treatment of cutaneous and mucosal leishmaniasis",[101,102],"Leishmaniasis; Brazilian","Leishmaniasis, Mucocutaneous",[104,105,106,107,108,109],"Elderly","Miltefosine","Leishmaniasis","Pentoxifylline","Liposomal amphotericin b","Treatment","2023-09-13",{"date":112,"type":113},"2023-09-15","ACTUAL",{"date":115,"type":113},"2022-06-22",{"date":117,"type":94},"2026-06",{"name":5,"class":6},1]