[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608924":3},{"organization":4,"outcomesModule":7,"designInfo":117,"detailedDescription":120,"studyPopulation":121,"armGroups":122,"interventions":137,"overallOfficials":147,"centralContacts":152,"locations":160,"responsibleParty":289,"collaborators":291,"id":299,"slug":116,"hasResults":300,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":116,"eligibilityCriteria":304,"healthyVolunteers":300,"sex":305,"minAge":116,"maxAge":116,"enrollmentInfo":306,"targetDuration":116,"studyType":309,"phases":116,"briefSummary":310,"conditions":311,"keywords":313,"overallStatus":182,"whyStopped":116,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},{"fullName":5,"class":6},"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":94,"otherOutcomes":116},[9,13,15,17,19,21,23,25,27,29,33,35,37,39,41,43,47,50,53,56,59,62,65,67,69,72,74,76,78,80,82,84,86,88,90,92],{"measure":10,"description":11,"timeFrame":12},"Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester","Arm 1A","First on-study dose through 24 hours",{"measure":14,"description":11,"timeFrame":12},"Geometric mean terminal elimination half-life (t1\u002F2) in the first trimester",{"measure":16,"description":11,"timeFrame":12},"Geometric mean trough concentration (Ctrough) in the first trimester",{"measure":18,"description":11,"timeFrame":12},"Geometric mean AUC0-tau in the second trimester",{"measure":20,"description":11,"timeFrame":12},"Geometric mean t1\u002F2 in the second trimester",{"measure":22,"description":11,"timeFrame":12},"Geometric mean Ctrough in the second trimester",{"measure":24,"description":11,"timeFrame":12},"Geometric mean AUC0-tau in the third trimester",{"measure":26,"description":11,"timeFrame":12},"Geometric mean t1\u002F2 in the third trimester",{"measure":28,"description":11,"timeFrame":12},"Geometric mean Ctrough in the third trimester",{"measure":30,"description":31,"timeFrame":32},"Median maximum plasma concentration during the dose interval (Cmax) in the first trimester","Arm 1B","First on-study dose through up to 24 hours",{"measure":34,"description":31,"timeFrame":32},"Median time to Cmax (Tmax) in the first trimester",{"measure":36,"description":31,"timeFrame":32},"Median Cmax in the second trimester",{"measure":38,"description":31,"timeFrame":32},"Median Tmax in the second trimester",{"measure":40,"description":31,"timeFrame":32},"Median Cmax in the third trimester",{"measure":42,"description":31,"timeFrame":32},"Median Tmax in the third trimester",{"measure":44,"description":45,"timeFrame":46},"Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester","Arm 2","First on-study dose through 7 days",{"measure":48,"description":45,"timeFrame":49},"Geometric mean AUC at 14 days (AUC0-14d) in the first trimester","First on-study dose through 14 days",{"measure":51,"description":45,"timeFrame":52},"Geometric mean plasma concentration at 2 hours (C2h) in the first trimester","2 hours post-first on-study dose",{"measure":54,"description":45,"timeFrame":55},"Geometric mean plasma concentration at 24 hours (C24h) in the first trimester","24 hours post-first on-study dose",{"measure":57,"description":45,"timeFrame":58},"Geometric mean plasma concentration at 4 days (C4d) in the first trimester","4 days post-first on-study dose",{"measure":60,"description":45,"timeFrame":61},"Geometric mean plasma concentration at 7 days (C7d) in the first trimester","7 days post-first on-study dose",{"measure":63,"description":45,"timeFrame":64},"Geometric mean plasma concentration at 14 days (C14d) in the first trimester","14 days post-first on-study dose",{"measure":66,"description":45,"timeFrame":46},"Geometric mean AUC0-7d in the second trimester",{"measure":68,"description":45,"timeFrame":49},"Geometric mean AUC0-14d in the second trimester",{"measure":70,"description":71,"timeFrame":52},"Geometric mean C2h in the second trimester","Arm 2 (as defined above)",{"measure":73,"description":71,"timeFrame":55},"Geometric mean C24h in the second trimester",{"measure":75,"description":71,"timeFrame":58},"Geometric mean C4d in the second trimester",{"measure":77,"description":71,"timeFrame":61},"Geometric mean C7d in the second trimester",{"measure":79,"description":71,"timeFrame":64},"Geometric mean C14d in the second trimester",{"measure":81,"description":45,"timeFrame":46},"Geometric mean AUC0-7d in the third trimester",{"measure":83,"description":45,"timeFrame":49},"Geometric mean AUC0-14d in the third trimester",{"measure":85,"description":71,"timeFrame":52},"Geometric mean C2h in the third trimester",{"measure":87,"description":71,"timeFrame":55},"Geometric mean C24h in the third trimester",{"measure":89,"description":71,"timeFrame":58},"Geometric mean C4d in the third trimester",{"measure":91,"description":71,"timeFrame":61},"Geometric mean C7d in the third trimester",{"measure":93,"description":71,"timeFrame":64},"Geometric mean C14d in the third trimester",[95,98,100,103,104,108,110,112,114],{"measure":96,"description":97,"timeFrame":46},"Proportion of participants with a maternal serious adverse event (SAE)","Arm 1A and Arm 1B",{"measure":99,"description":97,"timeFrame":46},"Proportion of participants with a maternal SAE assessed as related to drug under study",{"measure":101,"description":45,"timeFrame":102},"Proportion of participants with a maternal SAE","First on-study dose through up to 28 days",{"measure":99,"description":45,"timeFrame":102},{"measure":105,"description":106,"timeFrame":107},"Proportion of participants with a spontaneous abortion or miscarriage (\u003C20 weeks gestation)","Arm 1A, Arm1B, and Arm 2","At pregnancy outcome\u002Fdelivery\u002Fbirth",{"measure":109,"description":106,"timeFrame":107},"Proportion of participants with a stillbirth (≥20 weeks gestation)",{"measure":111,"description":106,"timeFrame":107},"Proportion of participants with an infant small for gestational age (SGA; weight \u003C10th percentile for gestational age, adjusted for sex)",{"measure":113,"description":106,"timeFrame":107},"Proportion of participants with a preterm birth (\u003C37 weeks gestation)",{"measure":115,"description":106,"timeFrame":107},"Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP)",null,{"allocation":116,"interventionModel":116,"interventionModelDescription":116,"primaryPurpose":116,"observationalModel":118,"timePerspective":119,"maskingInfo":116},"COHORT","PROSPECTIVE","IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy.\n\nThe study includes two arms, with Arm 1 subdivided by route of administration:\n\nArm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G","Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.",[123,128,132],{"label":124,"type":116,"description":125,"interventionNames":126},"Active comparator: Arm 1A: IV ceftriaxone","Intravenous ceftriaxone",[127],"Drug: Ceftriaxon",{"label":129,"type":116,"description":130,"interventionNames":131},"Active Comparator: Arm 1B: IM ceftriaxone","Intramuscular ceftriaxone",[127],{"label":133,"type":116,"description":134,"interventionNames":135},"Active Comparator: Arm 2: IM benzathine penicillin G","Intramuscular benzathine penicillin G",[136],"Drug: Benzathine penicillin G",[138,143],{"type":139,"name":140,"description":141,"armGroupLabels":142,"otherNames":116},"DRUG","Ceftriaxon","Ceftriaxone will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider",[129,124],{"type":139,"name":144,"description":145,"armGroupLabels":146,"otherNames":116},"Benzathine penicillin G","Benzathine penicillin G will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider",[133],[148],{"name":149,"affiliation":150,"role":151},"Jason Zucker","Columbia Physicians & Surgeons (P&S) CRS","STUDY_CHAIR",[153,158],{"name":154,"role":155,"phone":156,"phoneExt":116,"email":157},"Lisa Levy","CONTACT","2028848480","impaact.ctgov@fstrf.org",{"name":154,"role":155,"phone":156,"phoneExt":116,"email":159},"llevy@fhi360.org",[161,180,192,207,218,233,247,258,273],{"facility":162,"status":163,"city":164,"state":165,"zip":166,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":174,"contacts":175},"Site 5048, USC - Maternal Child Adolescent\u002FAdult Center","NOT_YET_RECRUITING","Los Angeles","California","90033","United States","US",{"type":170,"coordinates":171},"Point",[172,173],-118.24368,34.05223,{"lat":173,"lon":172},[176],{"name":177,"role":155,"phone":178,"phoneExt":116,"email":179},"Alice Stek","323-865-1585","stek@usc.edu",{"facility":181,"status":182,"city":164,"state":165,"zip":183,"country":167,"countryCode":168,"cosmosGeoPoint":184,"geoPoint":186,"contacts":187},"Site 5112, David Geffen School of Medicine at UCLA NICHD CRS","RECRUITING","90095",{"type":170,"coordinates":185},[172,173],{"lat":173,"lon":172},[188],{"name":189,"role":155,"phone":190,"phoneExt":116,"email":191},"Jaime Deville","310-825-9660","jdeville@mednet.ucla.edu",{"facility":193,"status":163,"city":194,"state":195,"zip":196,"country":167,"countryCode":168,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS","Chicago","Illinois","60612",{"type":170,"coordinates":198},[199,200],-87.65005,41.85003,{"lat":200,"lon":199},[203],{"name":204,"role":155,"phone":205,"phoneExt":116,"email":206},"Miriam Aziz","312-572-4265","mariam_aziz@rush.edu",{"facility":208,"status":182,"city":194,"state":195,"zip":209,"country":167,"countryCode":168,"cosmosGeoPoint":210,"geoPoint":212,"contacts":213},"Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS","60614",{"type":170,"coordinates":211},[199,200],{"lat":200,"lon":199},[214],{"name":215,"role":155,"phone":216,"phoneExt":116,"email":217},"Jennifer Jao","312-227-4080","JJao@luriechildrens.org",{"facility":219,"status":182,"city":220,"state":221,"zip":222,"country":167,"countryCode":168,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Site 5040, SUNY Stony Brook NICHD CRS","Stony Brook","New York","11794",{"type":170,"coordinates":224},[225,226],-73.14094,40.92565,{"lat":226,"lon":225},[229],{"name":230,"role":155,"phone":231,"phoneExt":116,"email":232},"Sharon Nachman","631-444-7692","sharon.nachman@stonybrookmedicine.edu",{"facility":234,"status":182,"city":235,"state":221,"zip":236,"country":167,"countryCode":168,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Site 5114, Bronx-Lebanon Hospital Center NICHD CRS","The Bronx","10457",{"type":170,"coordinates":238},[239,240],-73.86641,40.84985,{"lat":240,"lon":239},[243],{"name":244,"role":155,"phone":245,"phoneExt":116,"email":246},"Murli Purswani","718-960-1010","mpurswan@bronxcare.org",{"facility":248,"status":163,"city":235,"state":221,"zip":249,"country":167,"countryCode":168,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},"Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS","10461",{"type":170,"coordinates":251},[239,240],{"lat":240,"lon":239},[254],{"name":255,"role":155,"phone":256,"phoneExt":116,"email":257},"Andrew Wiznia","718-918-4664","andrew.wiznia@einsteinmed.edu",{"facility":259,"status":163,"city":260,"state":261,"zip":262,"country":167,"countryCode":168,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Site 5128, Baylor College of Medicine\u002FTexas Children's Hospital NICHD CRS","Houston","Texas","77030",{"type":170,"coordinates":264},[265,266],-95.36327,29.76328,{"lat":266,"lon":265},[269],{"name":270,"role":155,"phone":271,"phoneExt":116,"email":272},"Mary Paul","832-822-1038","mpaul@bcm.edu",{"facility":274,"status":163,"city":275,"state":116,"zip":276,"country":277,"countryCode":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Site 5129, IMPAACT\u002FGamma Project\u002FUPR Pediatric HIV\u002FAIDS Research CRS","San Juan","00935","Puerto Rico","PR",{"type":170,"coordinates":280},[281,282],-66.10572,18.46633,{"lat":282,"lon":281},[285],{"name":286,"role":155,"phone":287,"phoneExt":116,"email":288},"Irma Febo","787-759-9595","irma.febo2@upr.edu",{"type":290,"investigatorFullName":116,"investigatorTitle":116,"investigatorAffiliation":116,"oldNameTitle":116,"oldOrganization":116},"SPONSOR",[292,295,297],{"name":293,"class":294},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":296,"class":294},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)",{"name":298,"class":294},"National Institute of Mental Health (NIMH)","100608924",false,"NCT07207876","Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy","Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy","Inclusion Criteria:\n\n* Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation\n* At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate\n* At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:\n\n  * Ceftriaxone: IV or IM administration for an indication other than syphilis\n  * Benzathine penicillin G: IM administration for treatment of syphilis\n* At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum\n\nExclusion Criteria:\n\n* Previously enrolled in this study\n* Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records\n* Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:\n\n  * Current indication for hemodialysis\n  * Current indication for intensive care unit hospitalization\n  * Creatinine (Cr) ≥ 3.5 x upper limit of normal (ULN) at any time during the current pregnancy and\u002For chronic kidney disease Stage 5\n* Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:\n\n  * Probenecid\n  * Penicillin\n* Arm 1A: any penicillin\n* Arm 1B: any penicillin\n* Arm 2: penicillin other than benzathine penicillin G\n\n  * Benzapril\n  * Chlorpropamide\n  * Diflunisal\n  * Irbesartan\n  * Ketoprofen\n  * Ketorolac tromethamine\n  * Meclofenamic acid\n  * Mefenamic acid\n  * Oxaprozin\n  * Parecoxib\n  * Penciclovir\n  * Pioglitazone\n  * Telmisartan\n  * Valsartan\n* Receipt of any investigational agent within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records\n* Has any documented or suspected clinically significant condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives","FEMALE",{"count":307,"type":308},110,"ESTIMATED","OBSERVATIONAL","IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.",[312],"Pregnancy",[314,315,312,316],"Cefriaxone","Syphilis","Benzathine Penicillin G","2026-03-25",{"date":319,"type":320},"2026-03-27","ACTUAL",{"date":322,"type":320},"2026-02-16",{"date":324,"type":308},"2027-05-17",{"name":5,"class":6},9]