[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100178855":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":21,"centralContacts":10,"locations":28,"responsibleParty":179,"collaborators":10,"id":181,"slug":182,"hasResults":183,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":10,"eligibilityCriteria":187,"healthyVolunteers":188,"sex":189,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":10,"studyType":195,"phases":10,"briefSummary":196,"conditions":197,"keywords":10,"overallStatus":199,"whyStopped":10,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,12,15,18],{"label":9,"type":10,"description":11,"interventionNames":10},"Group 1",null,"≤ 27 weeks 6 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.",{"label":13,"type":10,"description":14,"interventionNames":10},"Group 2","≤ 27 weeks 6 days gestational age at birth and \\> 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.",{"label":16,"type":10,"description":17,"interventionNames":10},"Group 3","≥ 28 weeks 0 days gestational age at birth and ≤ 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.",{"label":19,"type":10,"description":20,"interventionNames":10},"Group 4","≥ 28 weeks 0 days gestational age at birth and \\> 30 days chronologic age at study enrollment. Dose and duration of intravenous ganciclovir therapy is at the discretion of the treating physician and will not be dictated by the research protocol.",[22,26],{"name":23,"affiliation":24,"role":25},"David Kimberlin, MD","University of Birmingham at Alabama","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Richard Whitley, MD",[29,41,51,61,71,81,91,101,111,120,130,140,149,159,169],{"facility":5,"status":10,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":10},"Birmingham","Alabama","35233","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-86.80249,33.52066,{"lat":39,"lon":38},{"facility":42,"status":10,"city":43,"state":44,"zip":45,"country":33,"countryCode":34,"cosmosGeoPoint":46,"geoPoint":50,"contacts":10},"University of Arkansas for Medical Sciences","Little Rock","Arkansas","72202",{"type":36,"coordinates":47},[48,49],-92.28959,34.74648,{"lat":49,"lon":48},{"facility":52,"status":10,"city":53,"state":54,"zip":55,"country":33,"countryCode":34,"cosmosGeoPoint":56,"geoPoint":60,"contacts":10},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"type":36,"coordinates":57},[58,59],-77.03637,38.89511,{"lat":59,"lon":58},{"facility":62,"status":10,"city":63,"state":64,"zip":65,"country":33,"countryCode":34,"cosmosGeoPoint":66,"geoPoint":70,"contacts":10},"University of South Florida School of Medicine","St. Petersburg","Florida","33701",{"type":36,"coordinates":67},[68,69],-82.67927,27.77086,{"lat":69,"lon":68},{"facility":72,"status":10,"city":73,"state":74,"zip":75,"country":33,"countryCode":34,"cosmosGeoPoint":76,"geoPoint":80,"contacts":10},"Louisiana State University Health Science Center - 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Charlotte","Charlotte","North Carolina","28203",{"type":36,"coordinates":126},[127,128],-80.84313,35.22709,{"lat":128,"lon":127},{"facility":131,"status":10,"city":132,"state":133,"zip":134,"country":33,"countryCode":34,"cosmosGeoPoint":135,"geoPoint":139,"contacts":10},"MetroHealth Medical Center","Cleveland","Ohio","44109",{"type":36,"coordinates":136},[137,138],-81.69541,41.4995,{"lat":138,"lon":137},{"facility":141,"status":10,"city":142,"state":133,"zip":143,"country":33,"countryCode":34,"cosmosGeoPoint":144,"geoPoint":148,"contacts":10},"Nationwide Childrens Hospital","Columbus","43205",{"type":36,"coordinates":145},[146,147],-82.99879,39.96118,{"lat":147,"lon":146},{"facility":150,"status":10,"city":151,"state":152,"zip":153,"country":33,"countryCode":34,"cosmosGeoPoint":154,"geoPoint":158,"contacts":10},"Children's Hospital of Pittsburgh of UPMC","Pittsburgh","Pennsylvania","15224",{"type":36,"coordinates":155},[156,157],-79.99589,40.44062,{"lat":157,"lon":156},{"facility":160,"status":10,"city":161,"state":162,"zip":163,"country":33,"countryCode":34,"cosmosGeoPoint":164,"geoPoint":168,"contacts":10},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":36,"coordinates":165},[166,167],-71.41283,41.82399,{"lat":167,"lon":166},{"facility":170,"status":10,"city":171,"state":172,"zip":173,"country":33,"countryCode":34,"cosmosGeoPoint":174,"geoPoint":178,"contacts":10},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":36,"coordinates":175},[176,177],-86.78444,36.16589,{"lat":177,"lon":176},{"type":25,"investigatorFullName":23,"investigatorTitle":180,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Protocol Principal and Lead Investigator","100178855","evaluation-of-the-pharmacokinetics-pk-and-pharmacodymamics-pd-of-ganciclovir-gcv-in-premature-infants-receiving-treatment-for-cytomegalorivus-cmv-infection-100178855",true,"NCT01602614","Evaluation of the Pharmacokinetics (PK) and Pharmacodymamics (PD) of Ganciclovir (GCV) in Premature Infants Receiving Treatment for Cytomegalorivus (CMV) Infection","Evaluation of the Pharmacokinetics and Pharmacodynamics of Ganciclovir in Premature Infants Receiving Treatment for Cytomegalovirus Infection","Inclusion Criteria:\n\n1. Signed informed consent from parent(s) or legal guardian(s)\n2. Confirmation of CMV infection from urine, blood, or saliva by culture, shell vial, or PCR tests (local lab)\n3. Receiving intravenous ganciclovir, prescribed by the patient's physician\n4. \\\u003C 32 weeks gestational age at birth\n5. ≥ 500 grams at study enrollment\n\nExclusion Criteria:\n\n1. Imminent demise\n2. Current receipt of valganciclovir or foscarnet\n3. Receiving breast milk from a mother who is being treated with ganciclovir or valganciclovir\n4. Current receipt of other investigational drugs\n5. Major congenital anomaly that in the site investigator's opinion may impact drug metabolism or the patient's volume of distribution",false,"ALL","1 Day","180 Days",{"count":193,"type":194},18,"ACTUAL","OBSERVATIONAL","This is a clinical sampling study, and no study drugs will be administered under this protocol. Premature infants who receive intravenous ganciclovir as part of clinical care will be eligible for participation in this study. Intravenous ganciclovir will not be provided under this protocol.",[198],"Cytomegalovirus Infections","COMPLETED","2020-05-18",{"date":202,"type":194},"2020-06-02",{"date":204,"type":10},"2013-04",{"date":206,"type":194},"2019-03",{"name":5,"class":6},15]