[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"syphilis-congenital\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:syphilis-congenital":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,71,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100636629","ultrasound-guided-long-vs-short-peripheral-iv-catheters-in-neonates-with-congenital-syphilis-receiving-antibiotics-100636629",false,"NCT07568171","Ultrasound-Guided Long vs Short Peripheral IV Catheters in Neonates With Congenital Syphilis Receiving Antibiotics","Ultrasound-Guided Long Peripheral Intravenous Catheters Versus Conventional Short Peripheral Catheters for Reducing Post-Insertion Failure in Neonates With Congenital Syphilis Receiving Antibiotic Therapy: A Randomized Clinical Trial","ULTRA-ACCESS","Inclusion Criteria:\n\n* Newborns admitted to the Neonatal Intermediate Care Unit;\n* Diagnosis of congenital syphilis;\n* Indication for intravenous penicillin therapy for an estimated duration of 10 days;\n* Enrollment on the first day of treatment.\n\nExclusion Criteria:\n\n* Newborns who have received any type of peripheral venous catheter prior to study enrollment;\n* Clinical instability at the time of vascular access indication and\u002For requirement for admission to a Neonatal Intensive Care Unit;\n* Requirement for concomitant administration of another antimicrobial agent in addition to crystalline penicillin;\n* Need for catheter insertion outside the operating hours of the Vascular Access Program (7:00 AM to 7:00 PM, Monday to Friday).","ALL","1 Day","28 Days",{"count":21,"type":22},104,"ESTIMATED","INTERVENTIONAL",[25],"NA","Congenital syphilis in newborns requires intravenous antibiotic therapy, making reliable peripheral venous access essential. However, high rates of catheter failure and repeated punctures remain a significant clinical challenge. This randomized, controlled, parallel clinical trial aims to compare ultrasound-guided long peripheral intravenous catheters inserted by a specialized vascular access team with conventional short peripheral catheters inserted by neonatal nurses. A total of 104 newborns with congenital syphilis receiving intravenous penicillin will be randomly assigned to either group. The primary outcome is functional dwell time. Secondary outcomes include catheter failure, number of insertion attempts, first-attempt success, complications, and total number of devices required. The study hypothesizes that ultrasound-guided long peripheral catheters will improve vascular access outcomes, reduce complications, and minimize the need for repeated punctures.",[28,29,30,31,32,33,34],"Infant, Newborn","Syphilis, Congenital","Catheterization, Peripheral","Ultrasonography","Advanced Practice Nursing","Patient Safety","Neonatal Nursing","NOT_YET_RECRUITING","2026-05-06",{"date":38,"type":39},"2026-05-11","ACTUAL",{"date":41,"type":22},"2026-05",{"date":43,"type":22},"2028-12",{"name":45,"class":46},"Hospital de Clinicas de Porto Alegre","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100586886","phase-2-comprehensive-ambulatory-antibiotics-for-the-treatment-of-congenital-syphilis-100586886","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","0 Days","7 Days",{"count":57,"type":22},90,[59],"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.",[29],"RECRUITING",{"date":38,"type":39},{"date":65,"type":39},"2026-05-04",{"date":67,"type":22},"2027-06-30",{"name":69,"class":46},"London School of Hygiene and Tropical Medicine",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100628111","phase-4-congenital-syphilis-treatment-trial-consistent-in-neonates-100628111","NCT07457385","Congenital Syphilis Treatment Trial (CONSISTENT) in Neonates","Congenital Syphilis Treatment Trial (CONSISTENT): Phase IV, Open-label, Randomized Controlled Trial of Amoxicillin vs. Benzathine in Neonates With Possible Congenital Syphilis","Inclusion Criteria:\n\n1. Confirmed staged maternal syphilis in pregnancy with rapid plasma reagin (RPR) + and T. pallidum hemagglutination antibody (TPHA) or other evidence of active syphilis (i.e. ulcerative anogenital lesion with positive darkfield microscopy or PCR+ for T. pallidum)\n2. Inadequate therapy (non-BPG regimen, incomplete regimen for stage, \\\u003C30 days prior to delivery), undocumented therapy, or lack of maternal syphilis therapy in pregnancy\n3. Infant age ≤ 30 days old\n4. Gestational age at birth ≥35 weeks\n5. Infant birth weight ≥ 750 grams\n6. Infant tolerating oral feeds\n7. Normal infant examination, laboratory, and radiographic evaluation: hemoglobin, platelet count, CSF (cell count, protein, VDRL), long-bone radiographs\n8. Infant quantitative RPR reactive and ≤ 4-fold lower titer compared with maternal RPR\n9. Parent(s) or legal guardian(s) capable and willing to provide informed consent\n\nExclusion Criteria:\n\n1. Infant receipt of antibiotics between birth and enrollment with activity against T. pallidum (including beta-lactam, cephalosporin, or azithromycin)\n2. Uncontrolled maternal HIV (viral load \\>1000 copies\u002FmL at or within 4 weeks of delivery) or HIV-exposed infants who require three drug antiretroviral post exposure prophylaxis.\n3. Unable to ensure infant follow up through six months of age","30 Days",{"count":80,"type":22},374,[82],"PHASE4","The Investigator hypothesize that the treatment efficacy will be similar in both study arms. Secondary outcomes and endpoints will characterize safety by comparing adverse events (AEs), tolerability, and adherence to therapy in each arm.\n\nThis is a Phase 4, open-label, multicenter trial designed to evaluate the efficacy of a single injected dose of intramuscular (IM) BPG (Arm 1) compared to oral amoxicillin administered twice daily (BID) for 10 days (Arm 2). The study will involve infants aged ≤ 30 days old with suspected untreated syphilis. The trial will be conducted at 12 sites across the U.S., enrolling approximately 374 participants.\n\nUpon randomization, participants will undergo baseline study sample collection (blood, oropharyngeal, and nasal mucosal swabs for PCR testing) and then receive either treatment with oral amoxicillin or IM BPG, both with directly observed therapy. The participant enrolled in the optional pharmacokinetic (PK) sub-study will have additional blood samples collected for PK analysis within the first 24-48 hours after treatment. Participants will be discharged from the hospital following routine procedures, with the oral amoxicillin dosing continued at home (BID) by the caregiver.",[29],"2026-03-03",{"date":87,"type":39},"2026-03-09",{"date":89,"type":22},"2026-11-01",{"date":91,"type":22},"2031-08-31",{"name":93,"class":46},"University of Alabama at Birmingham",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":101,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100606300","congenital-and-maternal-point-of-care-rapid-testing-for-syphilis-study-uganda-100606300","NCT07173764","Congenital and Maternal Point of Care Rapid Testing for Syphilis Study, Uganda","COMPARTS","Inclusion Criteria:\n\n* Mothers delivering at Kawempe National Referral Hospital with a positive syphilis rapid diagnostic test during their current pregnancy.\n\nExclusion Criteria:\n\n* Mothers who are unable to give written informed consent.\n* Mothers with evidence of neurological symptoms compatible with neurological syphilis.\n* Mothers who are aged less than 14 years. Emancipated and mature minors are allowed to consent for research per Ugandan law.11\n* Mothers, who in the view of the study team, are unable to adhere to required study procedures","14 Years",{"count":103,"type":22},24,"OBSERVATIONAL","Syphilis is an infection which affects about 1 in 25 pregnant women in Uganda. If the infection is not diagnosed and treated this can be a risk to the mother and unborn baby's health. This study aims to see whether a new test for syphilis infection in mothers and babies which can give a result in 10 minutes is as good as the standard tests that are done in the laboratory and take hours or days to provide results.",[107,29],"Syphilis",[109,110],"syphilis","point of care test","2025-09-08",{"date":113,"type":39},"2025-09-15",{"date":115,"type":22},"2025-09",{"date":117,"type":22},"2025-12",{"name":119,"class":46},"St George's, University of London",1]