[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100445727":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":74,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin Arm","EXPERIMENTAL","Melatonin 5 mg capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Arm","PLACEBO_COMPARATOR","Placebo capsule by mouth at bedtime for the duration of hospitalization or discontinuation of broad spectrum antibiotics, whichever comes first.",[19],"Other: Placebo Capsule",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Melatonin","Melatonin 5 mg capsule by mouth at bedtime",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Capsule","Placebo capsule by mouth at bedtime",[15],[32],{"name":33,"affiliation":5,"role":34},"Luigi Brunetti, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","908-595-2645","luigi.brunetti@rutgers.edu",[41,60],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Robert Wood Johnson University Hospital","RECRUITING","New Brunswick","New Jersey","08901","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-74.45182,40.48622,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":26,"email":59},"Pinki Bhatt, MD","732-235-2898","pb518@rwjms.rutgers.edu",{"facility":61,"status":43,"city":62,"state":45,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Robert Wood Johnson University Hospital Somerset","Somerville","08876",{"type":50,"coordinates":65},[66,67],-74.60988,40.57427,{"lat":67,"lon":66},[70,73],{"name":33,"role":37,"phone":71,"phoneExt":26,"email":72},"2016385868","brunetti@pharmacy.rutgers.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Luigi Brunetti","Associate Professor","100445727","phase-3-melatonin-for-prevention-of-kidney-injury-100445727",false,"NCT05084196","Melatonin for Prevention of Kidney Injury","Melatonin for the Prevention of Antibiotic Associated Acute Kidney Injury","Inclusion criteria:\n\n* Aged 18 to 75 years\n* Currently prescribed vancomycin with the presumption that therapy will be continued for at least 3 days based on a review of subject status. Because of the critical nature of starting empiric broad-spectrum antibiotics, we will allow one dose of the antibiotic combination before consent and enrollment. This strategy is necessary for the ethical conduct of the study.\n\nExclusion criteria:\n\n* Estimated creatinine clearance \\\u003C 30 mL\u002Fmin\n* Liver impairment (liver enzymes \\> 3 times upper limit)\n* Any history of allergy or contraindication to melatonin\n* Pregnancy or breastfeeding\n* Autoimmune disease\n* Requiring vasopressors\n* Requiring mechanical ventilation\n* History of acute kidney injury in the past 30 days\n* Inability to take oral medications\n* Clinical evidence of significant unstable or uncontrolled illness which, in the opinion of the research team, could confound the results of the study or put the patient at undue risk.","ALL","18 Years","75 Years",{"count":88,"type":89},300,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","This study will evaluate the safety and effectiveness of melatonin for the prevention of antibiotic associated acute kidney injury in hospitalized patients.",[95,96],"Acute Kidney Injury","Adverse Drug Event","2025-12-16",{"date":99,"type":100},"2025-12-17","ACTUAL",{"date":102,"type":100},"2023-06-05",{"date":104,"type":89},"2027-12-31",{"name":5,"class":6},2]