[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586886":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":43,"interventions":61,"overallOfficials":75,"centralContacts":82,"locations":88,"responsibleParty":136,"collaborators":138,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":161,"enrollmentInfo":162,"targetDuration":33,"studyType":165,"phases":166,"briefSummary":168,"conditions":169,"keywords":33,"overallStatus":91,"whyStopped":33,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"London School of Hygiene and Tropical Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":33},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Time above MIC in serum","Time above MIC of T. pallidum for the dosing interval in serum","From enrolment through to day 10 of the study",{"measure":14,"description":15,"timeFrame":16},"Time above MIC in CSF","Time above MIC in CSF throughout the dosing interval","10 days",{"measure":18,"description":19,"timeFrame":20},"Adverse Events","The proportion of individuals experiencing an adverse event through to week 24. The trial will record SAE, SUSARS, and drug related AEs of grade 3 or higher.","Assessed from enrolment through to 24 weeks",[22,26,30],{"measure":23,"description":24,"timeFrame":25},"Clinical Outcome","Proportion of infants who have clinical or laboratory evidence of congenital syphilis as adjudicated by an expert committee, blinded to treatment allocation, based on clinical and laboratory data.","Enrolment through to week 24",{"measure":27,"description":28,"timeFrame":29},"AUC\u002FMIC Ratio in serum","Proportion of individuals achieving an AUC\u002FMIC ratio ≥100 in serum","Enrolment through to day 10",{"measure":31,"description":32,"timeFrame":29},"AUC\u002FMIC Ratio in CSF","Proportion of individuals achieving an AUC\u002FMIC ratio ≥100 in CSF",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":39,"maskingDescription":40,"whoMasked":41},"SINGLE","It is not possible to blind the intervention to either participants or care providers given variation in route of administration and duration of therapy. Individuals assessing clinical and laboratory outcomes will be blinded to study group.",[42],"OUTCOMES_ASSESSOR",[44,50,55],{"label":45,"type":46,"description":47,"interventionNames":48},"Oral Linezolid","EXPERIMENTAL","10 day course of Linezolid twice a day",[49],"Drug: Linezolid (LZD)",{"label":51,"type":46,"description":52,"interventionNames":53},"Oral Amoxicillin","10 day course of Amoxicillin twice a day",[54],"Drug: Amoxicillin",{"label":56,"type":57,"description":58,"interventionNames":59},"IM Benzathine penicillin","ACTIVE_COMPARATOR","Single IM dose of IM Benzathine penicillin",[60],"Drug: Benzathine Penicillin G",[62,67,71],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":33},"DRUG","Linezolid (LZD)","Ten day course. Oral Linezolid dosed at 10mg\u002Fkg twice a day.",[45],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":33},"Amoxicillin","Ten day course. Oral Linezolid dosed at 50mg\u002Fkg twice a day.",[51],{"type":63,"name":72,"description":73,"armGroupLabels":74,"otherNames":33},"Benzathine Penicillin G","Single IM dose 50,000iu\u002Fkg",[56],[76,79],{"name":77,"affiliation":5,"role":78},"Michael Marks","PRINCIPAL_INVESTIGATOR",{"name":80,"affiliation":81,"role":78},"Bridget Freyne","University College Dublin",[83],{"name":84,"role":85,"phone":86,"phoneExt":33,"email":87},"Sarah Prentice","CONTACT","+4420 7636 8636","sarah.prentice@lshtm.ac.uk",[89,106,122],{"facility":90,"status":91,"city":92,"state":33,"zip":33,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Universitas Indonesia","RECRUITING","Jakarta","Indonesia","ID",{"type":96,"coordinates":97},"Point",[98,99],106.84513,-6.21462,{"lat":99,"lon":98},[102],{"name":103,"role":85,"phone":104,"phoneExt":33,"email":105},"Phoebe Williams","+61 2 9351 2222","phoebe.williams@sydney.edu.au \u003Cphoebe.williams@sydney.edu.au>",{"facility":107,"status":108,"city":109,"state":33,"zip":33,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Malawi Liverpool Wellcome Programme","NOT_YET_RECRUITING","Blantyre","Malawi","MW",{"type":96,"coordinates":113},[114,115],35.00854,-15.78499,{"lat":115,"lon":114},[118],{"name":119,"role":85,"phone":120,"phoneExt":33,"email":121},"Mary Mc Cauley","+265 111 81 19 18","mmccauley@mlw.mw",{"facility":123,"status":91,"city":123,"state":33,"zip":33,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Stellenbosch","South Africa","ZA",{"type":96,"coordinates":127},[128,129],18.86676,-33.93462,{"lat":129,"lon":128},[132],{"name":133,"role":85,"phone":134,"phoneExt":33,"email":135},"Lisa Frigati","+27 21 808 9111","frigati@sun.ac.za",{"type":137,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[139,140,142,143,145,147,150],{"name":81,"class":6},{"name":141,"class":6},"University of Stellenbosch",{"name":107,"class":6},{"name":144,"class":6},"University of Sydney",{"name":146,"class":6},"Murdoch Childrens Research Institute",{"name":148,"class":149},"MRC CTU at UCL","UNKNOWN",{"name":151,"class":149},"PHPT\u002FAMS Laboratory, Faculty of Associated Medical Sciences, Chiang Mai University","100586886","phase-2-comprehensive-ambulatory-antibiotics-for-the-treatment-of-congenital-syphilis-100586886",false,"NCT06921213","Comprehensive Ambulatory Antibiotics for the Treatment of Congenital Syphilis","Cares-1","Inclusion Criteria:\n\n1. Infants at risk of congenital syphilis at birth defined as:\n\n   1. an infant born to a mother who tests positive for syphilis in pregnancy using registered and licensed locally-available diagnostic tests for example but not limited to a Treponemal rapid POCT, an RPR or both.\n\n      AND\n   2. the mother is untreated in the current pregnancy defined as:\n\n   i. she tested positive at antenatal care and received no treatment OR ii. she was never tested during antenatal care OR iii. she tested negative at antenatal care and positive on re-testing at delivery\n\n   OR c. the mother is inadequately treated in the current pregnancy defined as:\n\n   i. Having received a non-penicillin based treatment regimen; and\u002For ii. Does not have documentation of 3 doses of IM Benzathine Penicillin, given 7-10 days apart, with the last dose given \\> 30 days prior to delivery OR b. The mother was adequately treated in the current pregnancy BUT considers herself at risk of re-infection following a midwife delivered explanation of risk (partner treatment, multiple partners etc).\n2. Infants who are asymptomatic for a diagnosis of congenital syphilis following application of a clinical proforma by the study team (Appendix 1)\n3. Infants who are less than \\\u003C= 7 days of life AND with a post-menstrual age (PMA) of 34-42 weeks (Appendix 2).\n4. Infants who are tolerating enteral feeds, including if they are being administered by an NG tube.\n\nExclusion Criteria:\n\n\\- 1. The infant's clinical condition at birth or prior to randomisation requires ongoing (\\> 48 hours) treatment with antibiotics with the potential for anti-treponemal activity i.e. B-lactams, Cephalosporins, Carbapenems.\n\n2\\. They have a birthweight \\\u003C2kg 3. They are nil by mouth. 4. They have a life-limiting congenital anomaly","ALL","0 Days","7 Days",{"count":163,"type":164},90,"ESTIMATED","INTERVENTIONAL",[167],"PHASE2","CARES-1 is a randomised, open-label, phase II pharmacokinetic (PK) and safety study of ambulatory antibiotics for the treatment of neonates with \"all-risk\" asymptomatic congenital syphilis.",[170],"Syphilis, Congenital","2026-08-10",{"date":173,"type":174},"2026-08-11","ACTUAL",{"date":176,"type":174},"2026-05-04",{"date":178,"type":164},"2027-06-30",{"name":5,"class":6},3]