[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546525":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":55,"centralContacts":61,"locations":66,"responsibleParty":101,"collaborators":30,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":30,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":30,"enrollmentInfo":113,"targetDuration":30,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":69,"whyStopped":30,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Participants randomized to the intervention group will receive the following regimen:\n\n* Ceftriaxone 1 g IV q 24 hours x 7 days\n* Clarithromycin 500 mg PO BID x 7 days\n* Metronidazole 500 mg PO q 12 hours x 7 days",[13,14,15],"Drug: Ceftriaxone 1000 MG","Drug: Clarithromycin 500mg","Drug: Metronidazole 500 mg",{"label":17,"type":6,"description":18,"interventionNames":19},"Standard of care","Participants randomized to the standard care group will receive the following regimen:\n\n* Ampicillin 2 g IV q 6 hours x 48 hours followed by amoxicillin 250 mg q 8 hours for an additional 5 days\n* Azithromycin 1 g PO x 1 dose OR erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days",[20,21,22,23],"Drug: Ampicillin 2 GM Injection","Drug: Amoxicillin 250 MG","Drug: Azithromycin","Drug: Erythromycin",[25,31,35,39,43,47,51],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ceftriaxone 1000 MG","Ceftriaxone 1 g IV q 24 hours x 7 days (in addition to clarithromycin and metronidazole)",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Clarithromycin 500mg","Clarithromycin 500 mg PO BID x 7 days (in addition to ceftriaxone and metronidazole)",[9],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Metronidazole 500 mg","Metronidazole 500 mg PO q 12 hours x 7 days (in addition to clarithromycin and ceftriaxone)",[9],{"type":26,"name":40,"description":41,"armGroupLabels":42,"otherNames":30},"Ampicillin 2 GM Injection","Ampicillin 2 g IV q 6 hours x 48 hours (prior to amoxicillin and in addition to either azithromycin or erythromycin)",[17],{"type":26,"name":44,"description":45,"armGroupLabels":46,"otherNames":30},"Amoxicillin 250 MG","Amoxicillin 250 mg q 8 hours for an additional 5 days (following ampicillin and in addition to either azithromycin or erythromycin)",[17],{"type":26,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Azithromycin","Azithromycin 1 g PO x 1 dose (in addition to ampicillin and amoxicillin)",[17],{"type":26,"name":52,"description":53,"armGroupLabels":54,"otherNames":30},"Erythromycin","Erythromycin 250 mg IV q 6 hours x 48 hours followed by erythromycin 333 mg PO TID for an additional 5 days (in addition to ampicillin and amoxicillin)",[17],[56,59],{"name":57,"affiliation":5,"role":58},"Marissa Berry, MD","PRINCIPAL_INVESTIGATOR",{"name":60,"affiliation":5,"role":58},"Kartik K Venkatesh, MD, PhD",[62],{"name":57,"role":63,"phone":64,"phoneExt":30,"email":65},"CONTACT","614-293-4780","Marissa.Berry@osumc.edu",[67,83],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"The Ohio State University Wexner Medical Center OB\u002FGYN Maternal and Fetal Medicine","RECRUITING","Columbus","Ohio","43210","United States","US",{"type":76,"coordinates":77},"Point",[78,79],-82.99879,39.96118,{"lat":79,"lon":78},[82],{"name":57,"role":63,"phone":64,"phoneExt":30,"email":65},{"facility":84,"status":69,"city":85,"state":86,"zip":87,"country":73,"countryCode":74,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"University of Texas Medical Branch","Galveston","Texas","775555",{"type":76,"coordinates":89},[90,91],-94.7977,29.30135,{"lat":91,"lon":90},[94,98],{"name":95,"role":63,"phone":96,"phoneExt":30,"email":97},"Benjamin Spires, MD","409-772-1193","bpspires@UTMB.EDU",{"name":99,"role":63,"phone":30,"phoneExt":30,"email":100},"Luis D Pacheco, MD","ldpachec@utmb.edu",{"type":58,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Kartik K Venkatesh","Principal Investigator","100546525","phase-4-improvement-of-pprom-management-with-prophylactic-antimicrobial-therapy-iprompt-100546525",false,"NCT06396078","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy (iPROMPT)","Improvement of PPROM Management With Prophylactic Antimicrobial Therapy","Inclusion criteria\n\n* Admitted to the inpatient unit for expectant management of PPROM until delivery\n* Age ≥ 18 years with the ability to provide informed consent\n* Gestational age between 23 0\u002F7 and 32 6\u002F7 weeks\n\nExclusion criteria\n\n* Having received more than one dose of any prophylactic antibiotic\n* Suspected or confirmed infection requiring treatment with antibiotics\n* Allergy or contraindication to an antibiotic in either arm\n* Maternal immunosuppression","FEMALE","18 Years",{"count":114,"type":115},56,"ESTIMATED","INTERVENTIONAL",[118],"PHASE4","To conduct an unblinded pragmatic randomized controlled trial (pRCT) \"Improvement of PPROM Management with Prophylactic Antimicrobial Therapy (iPROMPT)\" of a seven-day course of ceftriaxone, clarithromycin, and metronidazole versus the current standard of care of a seven-day course of ampicillin\u002Famoxicillin and azithromycin or erythromycin to prolong pregnancy and decrease adverse perinatal outcomes among hospitalized pregnant individuals undergoing expectant management of PPROM \\\u003C34 weeks.",[121,122,123],"Preterm Premature Rupture of Membrane","Pregnancy, High Risk","Preterm Birth",[125,126,127,128,129],"Pregnancy","Preterm premature rupture of membranes","Latency","Chorioamnionitis","Antibiotic prophylaxis","2026-01-23",{"date":132,"type":133},"2026-01-27","ACTUAL",{"date":135,"type":133},"2024-07-18",{"date":137,"type":115},"2026-12",{"name":5,"class":6},2]