[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640398":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Duke University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Short-course Ampicillin","EXPERIMENTAL","Infants enrolled in the trial receive short-course empiric ampicillin (24 to 36 hours, depending on gestational age and prescribed dosing regimen), rather than a standard (48 hour) empiric ampicillin course",[13],"Drug: Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis","preterm infants receive less than 48 hours of prescribed ampicillin (i.e., a \"short-course\" ampicillin regimen) to provide the desired 48 hours of therapeutic exposures",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Angelique Boutzoukas, MD, MPH","CONTACT","919-668-4733","angelique.boutzoukas@duke.edu",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Duke Health Neonatal Intensive Care Unit","Durham","North Carolina","27705","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-78.89862,35.99403,{"lat":39,"lon":38},[42,43,46],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},{"name":44,"role":24,"phone":20,"phoneExt":20,"email":45},"Stefany Olague, MPH","smalltrials-CRC@duke.edu",{"name":23,"role":47,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":49,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[51],{"name":52,"class":53},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100640398","phase-1-optimizing-preterm-infant-ampicillin-dosing-100640398",false,"NCT07610486","Optimizing PreTerm Infant Ampicillin Dosing","An Open-label, Pharmacokinetic and Safety Trial Optimizing PreTerm Infant Ampicillin Dosing","OPTI-Amp","Inclusion Criteria:\n\n* Documented informed consent from parent\u002Fguardian\n* Infants admitted to the Duke Neonatal Intensive Care Unit (NICU)\n* less than or equal to 34 completed weeks gestational age (GA) at birth and \\\u003C 7 days of life at time of screening\n* Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis\n\nExclusion Criteria:\n\n* Infant on extracorporeal support (e.g., ECMO)\n* Positive blood culture or other confirmed infection\n* At time of consent, infants with GA \\\u003C28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received \\> 32 to 36 hours of ampicillin, depending on dosing regimen\n* Has major congenital abnormalities where survival to 30 days of life is not expected\n* Failure to obtain consent from parent\u002Fguardian\n* Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA\n* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","0 Days","7 Days",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safety receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours). The main questions it aims to answer are:\n\n* Does short-course ampicillin provide high enough levels of ampicillin at 48 hours?\n* Is short-course ampicillin safe for preterm infants to receive?\n\nPreterm infants who are being prescribed ampicillin by their doctor and enroll in the study will stop ampicillin after a shorter than typical course, and researchers will collect blood samples to measure their ampicillin levels and follow them clinically to see how they do after receiving short-course ampicillin.\n\nParticipants will:\n\n* stop ampicillin earlier than 48 hours (between 24 to 36 hours, depending on how premature they are and the dosing of ampicillin their doctor has prescribed)\n* have a blood sample collected around 48 hours from when they started ampicillin\n* have their data collected until 30 days after they receive short-course ampicillin, or until hospital discharge, whichever is sooner",[74,75,76,77,78],"Early Onset Sepsis","Preterm Neonates","NICU","Ampicillin","Safety and Pharmacokinetics","NOT_YET_RECRUITING","2026-05-21",{"date":82,"type":83},"2026-05-28","ACTUAL",{"date":85,"type":67},"2026-07",{"date":87,"type":67},"2027-12",{"name":5,"class":6},1]