[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643878":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":64,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":26,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":26,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Antibiotic Regimen","ACTIVE_COMPARATOR","A single dose of oral azithromycin 1 gram which is given at the time of presentation in addition to the standard intravenous ampicillin 2g q6h for 48 hours followed by oral amoxicillin 250 mg q8 hours for 5 days.",[13],"Drug: Standard Azithromycin Dosing",{"label":15,"type":16,"description":17,"interventionNames":18},"Extended Azithromycin Regimen","EXPERIMENTAL","The standard antibiotic regimen will be given in addition to Azithromycin 500g every other day for 7 additional doses.",[19,13],"Drug: Azithromycin (Azithro)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azithromycin (Azithro)","Azithromycin 500 mg every other day for 7 additional doses will be given in addition to the standard antibiotic regimen.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Azithromycin Dosing","Oral Azithromycin 1g once.",[15,9],[32],{"name":33,"affiliation":34,"role":35},"Christina Megli, MD\u002FPhD","University of Pittsburgh Magee-Womens Hospital","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Alexa Henderson, MD","CONTACT","9136019107","hendersona8@upmc.edu",{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},"Christina Megli, MD, PhD","meglicj@upmc.edu",[46],{"facility":34,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Pittsburgh","Pennsylvania","15217","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-79.99589,40.44062,{"lat":56,"lon":55},[59,60,61,62],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":43,"role":39,"phone":26,"phoneExt":26,"email":44},{"name":43,"role":35,"phone":26,"phoneExt":26,"email":26},{"name":38,"role":63,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Alexa Henderson","Maternal Fetal Medicine Fellow","100643878","phase-4-extended-azithromycin-treatment-in-prelabor-rupture-of-membranes-100643878",false,"NCT07669207","Extended Azithromycin Treatment in Prelabor Rupture of Membranes","Extended Azithromycin Treatment in Peri-viable and Extremely Preterm Prelabor Rupture of Membranes: A Pilot Study","Inclusion Criteria:\n\n* Singleton gestation\n* Gestational age at time of PPROM between 22w0d and 28w0d\n* Opting for expectant management in the inpatient setting after completion of a maternal-fetal medicine and neonatology consultation (per standard of care)\n* Remain pregnant 48 hours after presentation.\n* Patients who receive betamethasone, magnesium therapy, and\u002For a limited course of tocolysis (through the betamethasone window) will be included.\n* Pregnant patients below the age of 18 are eligible.\n\nExclusion Criteria:\n\n* Contraindications to expectant management (clinical intra-amniotic infection, active preterm labor, or acute placental abruption)\n* Lethal congenital defects\n* Multiple gestation\n* Ongoing alternative antibiotic treatment\n* Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic\n* History of cholestatic jaundice\u002Fhepatic dysfunction associated with prior use of azithromycin\n* Known prolongation of QT interval\n* History of torsades de pointes\n* Congenital long QT syndrome\n* Bradyarrhythmia\n* Decompensated heart failure\n* Drugs known to significantly prolong the QT interval including Class 1A and Class III antiarrhythmic agents\n* Impaired hepatic function\n* GFR\\\u003C10 mL\u002Fmin\n* Diagnosis of myasthenia gravis","FEMALE",{"count":77,"type":78},30,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The purpose of this study is to learn whether adding extra doses of azithromycin to the standard antibiotic treatment for preterm prelabor rupture of membranes may improve pregnancy outcomes for patients between 22 weeks and 28 weeks gestational age.\n\nResearchers will compare the standard antibiotic treatment to the standard antibiotic treatment with additional doses of azithromycin.\n\nParticipants will:\n\n* Be randomly assigned to one of two groups:\n* The standard antibiotic treatment\n* The standard antibiotic treatment plus 7 additional doses of oral azithromycin 500 mg every other day.\n* Participants will be asked to complete a survey regarding their experience and side effects.",[84,85],"Preterm Prelabor Rupture of Membranes","PPROM",[87,88],"azithromycin","peri-viability","NOT_YET_RECRUITING","2026-06-21",{"date":92,"type":93},"2026-06-25","ACTUAL",{"date":95,"type":78},"2026-07-01",{"date":97,"type":78},"2028-07",{"name":66,"class":6},1]