[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555628":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":53,"collaborators":55,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":10,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-allometric dosing",null,"40 patients who will not use allometric dosing will be included\n\nmiltefosine will be given based on weight: 30-45 kg: 100mg miltefosine per day \\>45 kg: 150mg miltefosine per day",[13],"Drug: Miltefosine",{"label":15,"type":10,"description":16,"interventionNames":17},"allometric dosing (weight below 30 kg)","40 patients who weigh less than 30kg and therefore get allometric dosing will be recruited.\n\nDosing is given based on weight, height, and sex, according to Dorlo et al 2012",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DRUG","Miltefosine","Miltefosine will be prescribed by the treating physician for a minimum of 4 weeks. If treatment response is not sufficient, treatment extension could be decided by the treating physician up to 8 weeks",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Saskia Van Henten","Institute of Tropical Medicine","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"Shimelis Nigusse, MD","CONTACT","0911642060","shimelis321@gmail.com",[36],{"facility":37,"status":38,"city":39,"state":10,"zip":10,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital","RECRUITING","Addis Ababa","Ethiopia","ET",{"type":43,"coordinates":44},"Point",[45,46],38.74689,9.02497,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":51,"phoneExt":52,"email":34},"Shimelis Negusse, MD","09 11642060","+251",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[56,58,60,62],{"name":57,"class":6},"Alert Hospital, Ethiopia",{"name":59,"class":6},"Armauer Hansen Research Institute, Ethiopia",{"name":61,"class":6},"Uppsala University",{"name":63,"class":6},"The Netherlands Cancer Institute","100555628","optimizing-miltefosine-treatment-for-cutaneous-leishmaniasis-patients-100555628",false,"NCT06514560","OPTImizing MIltefosine Treatment for Cutaneous LEISHmaniasis Patients","OPTIMILEISH","Inclusion Criteria:\n\n* Clinical or parasitological (microscopy or PCR) confirmation of leishmaniasis\n* Age \\>2\n* Clinical decision to start miltefosine treatment as systemic treatment\n* In case of females of child-bearing age: willing to take contraceptive for 6 months (parenteral or IUD or implant)\n* Willing and able to provide informed consent\n* Willing to be hospitalized for the duration of treatment\n\nExclusion Criteria:\n\n* Currently on treatment or having received modern treatment for leishmaniasis in the last 3 months\n* Pregnant (pregnancy test at D0) or breastfeeding\n* Unlikely to come for follow-up visits\n* Abnormal lab values Hemoglobin \\\u003C5.0g\u002F100mL Platelets \\\u003C50 x 10\\^9\u002FL White blood count \\\u003C1 x 10\\^9\u002FL ASAT\u002FALAT \\>3x upper normal range Creatinine above the normal limit","ALL","2 Years",{"count":74,"type":75},80,"ESTIMATED","OBSERVATIONAL","While there are indications that 28 days of miltefosine is not sufficient for treating CL by L. aethiopica, a better understanding of what happens in terms of parasite clearance and drug dosing is lacking. In this study, longitudinal measurements of parasite and drug concentrations during treatment are done to monitor parasite kinetics as well as pharmacokinetics. This data will be crucial to provide more information on duration and dosing of miltefosine in CL patients globally, and in Ethiopia and pediatric patients in particular.",[79],"Cutaneous Leishmaniases","2024-07-16",{"date":82,"type":83},"2024-07-23","ACTUAL",{"date":85,"type":83},"2024-06-18",{"date":87,"type":75},"2026-12-30",{"name":5,"class":6},1]