[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533173":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":58,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":24,"enrollmentInfo":76,"targetDuration":24,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single dose rifampin (SDR)","EXPERIMENTAL","To household contacts of newly diagnosed leprosy patients SDR is provided as follows: 600 mg rifampicin for adults weighing 35 kg and over, 450 mg for adults weighing less than 35 kg and for children older than 9 years, and 300 mg for children aged 5 to 9 years.",[13],"Drug: Rifampin",{"label":15,"type":10,"description":16,"interventionNames":17},"Single double dose rifampin (SDDR)","To household contacts of newly diagnosed leprosy patients SDDR is provided as follows: 1200 mg rifampicin for adults weighing 35 kg and over, 900 mg for adults weighing less than 35 kg and for children older than 9 years, and 600 mg for children aged 5 to 9 years.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Rifampin","antibiotic",[9,15],null,[26],{"name":27,"affiliation":28,"role":29},"Annemieke Geluk, PhD","Academisch Ziekenhuis Leiden (LUMC)","PRINCIPAL_INVESTIGATOR",[31,35],{"name":27,"role":32,"phone":33,"phoneExt":24,"email":34},"CONTACT","+31715261974","ageluk@lumc.nl",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Anouk van Hooij, PhD","+31715263844","A.van_Hooij@lumc.nl",[40],{"facility":41,"status":42,"city":43,"state":24,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Leprosy Mission International - Bangladesh","RECRUITING","Nilphamari","5300","Bangladesh","BD",{"type":48,"coordinates":49},"Point",[50,51],88.84667,25.94167,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":56,"phoneExt":24,"email":57},"Abu Sufian Chowdhury, MD","+88 (0) 1713 362 720","dr.sufian@tlmbangladesh.org",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Annemieke Geluk","Prof. Dr. Annemieke Geluk",[63],{"name":64,"class":6},"The Leprosy Mission Bangladesh","100533173","novel-interventions-and-diagnostic-tests-for-leprosy-100533173",false,"NCT06222372","Novel Interventions and Diagnostic Tests for Leprosy","Monitoring the Effect of Prophylactic Interventions in Contacts of Leprosy Patients Including Field-application of a Novel Immunodiagnostic Test in Bangladesh","INDIGO#2","Inclusion Criteria patients:\n\n\\- newly diagnosed multibacillary leprosy patients (BI 1-6)\n\nInclusion Criteria contacts of MB leprosy patients:\n\n* living in the same house (household members)\n* living in a house on the same compound\n* sharing the same kitchen\n* direct neighbors (first neighbors)\n* willing to participate\n* provide informed consent\n\nExclusion Criteria patients:\n\n* refusal of examination of their contacts\n* suffering from the pure neural form of leprosy\n* residing only temporarily in the study area\n* PB leprosy patients\n\nExclusion Criteria contacts:\n\n* diagnosed as leprosy patients during contact examination\n* living less than 100 m away from a patient already included in the study\n* first and second degree relatives of a patient already included in the study\n* refusal informed consent\n* pregnancy\n* tuberculosis or leprosy treatment\n* below 5 years of age\n* known to suffer from liver disease or jaundice\n* residing temporarily in the study area",true,"ALL","5 Years",{"count":77,"type":78},1100,"ESTIMATED","INTERVENTIONAL",[81],"NA","Contact with Mycobacterium leprae (M. leprae) infected individuals is a risk factor for development of leprosy. Thus, detection of asymtomatically M. leprae infected individuals, allowing informed decision making on who needs treatment at a preclinical stage, is vital to interrupt transmission and can help prevent leprosy. In a previous field trial the BCG vaccine was applied alone and combined with a single dose of rifampin (SDR) as prophylactic interventions in contacts of leprosy patients in Bangladesh. Concurrently, blood-derived host immune-profiles specific for M. leprae infection or leprosy disease were assessed in the same population by merging detection of innate, adaptive cellular as well as humoral immunity. This has led to the identification of selected host-immune markers, currently applied in a low complexity lateral flow assay based on up-coverting particles (UCP-LFA), providing a convenient tool to assess M. leprae infection, allowing assessment of efficacy of prophylactic interventions in a point-of-care setting.\n\nThe proposed study aims to determine the effect of post-exposure prophylaxis by SDR on M. leprae infection rate using UCP-LFA before and after prophylaxis.",[84],"Leprosy",[86],"leprosy, diagnostics, SDR, post exposure prophylaxis (PEP), biomarkers, UCP-LFA","2025-09-09",{"date":89,"type":90},"2025-09-10","ACTUAL",{"date":92,"type":90},"2020-03-04",{"date":94,"type":78},"2026-12-15",{"name":60,"class":6},1]