[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555628":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":58,"studyPopulation":59,"armGroups":60,"interventions":70,"overallOfficials":76,"centralContacts":81,"locations":87,"responsibleParty":105,"collaborators":107,"id":116,"slug":55,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":55,"enrollmentInfo":124,"targetDuration":55,"studyType":127,"phases":55,"briefSummary":128,"conditions":129,"keywords":55,"overallStatus":90,"whyStopped":55,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Institute of Tropical Medicine, Belgium","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":33},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Miltefosine plasma concentrations - Area under the plasma concentration versus time curve (AUC)","Determined by LC-MS\u002FMS, miltefosine pharmacokinetics are assessed through calculation of the area under the plasma concentration-time curve from start of treatment until end of treatment (AUC0-EoT), stratified by whether patients received allometric dosing or not.","Day 0, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42\u002FDay 56, Day 90, Day 180",{"measure":14,"description":15,"timeFrame":12},"Miltefosine plasma concentrations - Maximum plasma concentration (Cmax)","Determined by LC-MS\u002FMS, stratified by whether patients received allometric dosing or not.",{"measure":17,"description":15,"timeFrame":12},"MIltefosine plasma concentrations - Time of maximum concentration (Tmax)",[19,22,25,29],{"measure":20,"description":21,"timeFrame":12},"Parasite kinetics in blood and skin","To determine parasite kinetics in terms of Ct-values in blood and skin (microbiopsy sample) measured by quantitative PCR",{"measure":23,"description":24,"timeFrame":12},"Adapted allometric dosing scheme specifically for children with CL","Population PK and PK-PD analysis of the relationship between miltefosine exposure and parasite kinetics will be done at UU, based on results from miltefosine plasma concentrations. Structural pharmacokinetic modelling will be used to develop and simulate alternative dosing schemes for children with CL, using Monte Carlo simulations.",{"measure":26,"description":27,"timeFrame":28},"Treatment outcomes of patients on miltefosine treatment","Clinical cure rate determined by complete flattening, complete reepithelization and absence of erythema, crustation, and swelling","Day 28, day 90 and day 180",{"measure":30,"description":31,"timeFrame":32},"Assess safety of miltefosine","Side-effects: number and proportion of patients with adverse events","Day 28",[34,38,42,46,50],{"measure":35,"description":36,"timeFrame":37},"To explore optimization of outcome assessment using a 3D scanner","Machine learning models will be built to explore accuracy (% correctly predicted) of 3D scanning models to predict clinical outcomes.","Day 28, Day 90, Day 180",{"measure":39,"description":40,"timeFrame":41},"To explore whether nutritional status in CL patients is related to treatment outcomes","Logistic regression models will be made with clinical cure\u002Fno cure as outcome, and nutritional status measured through Z-scores as predictor.","Nutritional status at Day 0, outcome at Day 90\u002FDay 180",{"measure":43,"description":44,"timeFrame":45},"To explore whether helminth infection in CL patients is related to treatment outcomes","Logistic regression models will be made with clinical cure\u002Fno cure as outcome, and helminth infection (determined as present\u002Fnot present by wet mount stool exam) as predictor.","Helminth infection at Day 0, outcome at Day 90\u002FDay 180",{"measure":47,"description":48,"timeFrame":49},"To explore sequencing to detect intrinsic and acquired resistance markers for miltefosine","Whole genome sequencing will be done at AHRI to check for intrinsic (before treatment samples) and acquired resistance (relapse and end of treatment samples).","Day 0, Day 28\u002FDay 42\u002FDay 56, unscheduled visit",{"measure":51,"description":52,"timeFrame":53},"To explore skin tissue miltefosine concentrations","Measured by LC-MS\u002FMS","Day 28\u002FDay 42\u002FDay 56",{"allocation":55,"interventionModel":55,"interventionModelDescription":55,"primaryPurpose":55,"observationalModel":56,"timePerspective":57,"maskingInfo":55},null,"COHORT","PROSPECTIVE","In this project, parasite dynamics and miltefosine pharmacokinetics in the skin and blood during routine durations of miltefosine treatment (4-8 weeks) are studied with the aim to provide evidence to optimize miltefosine dosing for treatment of CL. By also studying these factors in children who get allometric miltefosine dosing, data which can be used to adapt the current allometric dosing scheme specifically to children with CL will be produced. Exploratory objectives will look into searching for more objective outcome assessment measures, resistance, helminth infection and nutritional status as potential factors affecting treatment response.","A total of 40 children on allometric dosing and 40 other patients will be enrolled in the study",[61,66],{"label":62,"type":55,"description":63,"interventionNames":64},"Non-allometric dosing","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",[65],"Drug: Miltefosine",{"label":67,"type":55,"description":68,"interventionNames":69},"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",[65],[71],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":55},"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",[62,67],[77],{"name":78,"affiliation":79,"role":80},"Saskia Van Henten","Institute of Tropical Medicine","PRINCIPAL_INVESTIGATOR",[82],{"name":83,"role":84,"phone":85,"phoneExt":55,"email":86},"Shimelis Nigusse, MD","CONTACT","0911642060","shimelis321@gmail.com",[88],{"facility":89,"status":90,"city":91,"state":55,"zip":55,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":100},"Africa Leprosy, Tuberculosis, Rehabilitation and Training (ALERT) Hospital","RECRUITING","Addis Ababa","Ethiopia","ET",{"type":95,"coordinates":96},"Point",[97,98],38.74689,9.02497,{"lat":98,"lon":97},[101],{"name":102,"role":84,"phone":103,"phoneExt":104,"email":86},"Shimelis Negusse, MD","09 11642060","+251",{"type":106,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR",[108,110,112,114],{"name":109,"class":6},"Alert Hospital, Ethiopia",{"name":111,"class":6},"Armauer Hansen Research Institute, Ethiopia",{"name":113,"class":6},"Uppsala University",{"name":115,"class":6},"The Netherlands Cancer Institute","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":125,"type":126},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.",[130],"Cutaneous Leishmaniases","2024-07-16",{"date":133,"type":134},"2024-07-23","ACTUAL",{"date":136,"type":134},"2024-06-18",{"date":138,"type":126},"2026-12-30",{"name":5,"class":6},1]