[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616657":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":53,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Pomeranian Medical University Szczecin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ceftriaxone Prophylaxis","EXPERIMENTAL","Participants assigned to this arm will receive prophylactic ceftriaxone 1 g intravenously once daily, administered at a fixed morning time, starting 24 hours before hematopoietic stem cell infusion (Day -1) and continued until neutrophil recovery or the onset of infection symptoms. All participants undergo continuous body temperature monitoring and standardized microbiological diagnostics in case of fever or suspected infection.",[13],"Drug: Ceftriaxone 1000 MG",{"label":15,"type":16,"description":17,"interventionNames":18},"No Prophylaxis","NO_INTERVENTION","Participants in this arm will not receive prophylactic antibacterial therapy. They will undergo the same continuous body temperature monitoring as the intervention group. In case of fever or other indicators of infection, full microbiological diagnostics will be initiated and empirical antibiotic therapy will be started according to clinical judgment and local epidemiology.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Ceftriaxone 1000 MG","Participants in this arm receive prophylactic ceftriaxone administered intravenously at a dose of 1 g once daily. The infusion begins on Day -1 (24 hours before hematopoietic stem cell infusion) and continues until neutrophil recovery (ANC \\>500\u002Fµl for 3 consecutive days) or until signs of infection occur. Ceftriaxone is infused over at least 30 minutes after dissolving 1 g of the drug in 20-40 ml of an intravenous solution that does not contain calcium ions (e.g., 0.9% sodium chloride, 5% glucose, 10% glucose, or other compatible diluents specified in the protocol). Continuous real-time temperature monitoring is performed throughout the intervention period.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Sławomir Milczarek, MD","CONTACT","+48 881 241 284","slawomir.milczarek@pum.edu.pl",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Uniwersytecki zpital Kliniczny nr 1 im. prof. Tadeusza Sokołowskiego Pomorskiego Uniwersytetu Medycznego w Szczecinie","RECRUITING","Szczecin","West Pomeranian Voivodeship","71-252","Poland","PL",{"type":41,"coordinates":42},"Point",[43,44],14.55302,53.42894,{"lat":44,"lon":43},[47,51],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"Karolina Sorbian-Gajewska","505303518","karolina.sorbian.gajewska@pum.edu.pl",{"name":27,"role":52,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100616657","enhanced-molecular-microbiological-surveillance-versus-ceftriaxone-prophylaxis-in-hematopoietic-cell-transplant-patients-100616657",false,"NCT07308457","Enhanced Molecular Microbiological Surveillance Versus Ceftriaxone Prophylaxis in Hematopoietic Cell Transplant Patients","Comparison of Enhanced Molecular-Level Microbiological Surveillance and Ceftriaxone Prophylaxis in Patients Undergoing Hematopoietic Cell Transplantation: A Randomized, Prospective Medical Experiment","CRONOS","Inclusion Criteria:\n\n* Recipient of autologous or allogeneic hematopoietic stem cells from peripheral blood, bone marrow, or cord blood.\n* Age ≥18 years.\n* Ability to provide written informed consent.\n* No active infection for at least 2 weeks prior to transplantation.\n\nExclusion Criteria:\n\n* Controlled fungal infection.\n* Fever of unknown origin.\n* Ongoing antibiotic therapy (except cotrimoxazole).\n* Participation in any clinical study or experiment at the time of inclusion.","ALL","18 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70],"NA","The goal of this clinical trial is to learn whether close microbiological monitoring without preventive antibiotics works as well as preventive treatment with ceftriaxone in adults receiving stem cell transplants. The study focuses on people with blood cancers or other conditions who need either autologous or allogeneic hematopoietic stem cell transplantation (HSCT).\n\nThe main questions the study aims to answer are:\n\nWhat percentage of participants develop an infection when they do not receive preventive antibiotics compared with those who receive daily ceftriaxone?\n\nDoes preventive ceftriaxone lower the chance of specific complications such as bloodstream infections, pneumonia, or severe sepsis?\n\nResearchers will compare two groups:\n\none group will not receive preventive antibiotics\n\none group will receive ceftriaxone once a day until their white blood cells recover or until signs of infection appear\n\nAll participants will:\n\nhave their body temperature monitored continuously starting one day before the transplant\n\nhave blood, urine, or other samples collected if they develop fever or symptoms of infection\n\nreceive standard medical care during and after the transplant\n\nstart standard antibiotic treatment if they develop signs of infection\n\nThis study will include 100 adults. The information collected will help determine whether skipping preventive antibiotics is safe in hospitals where bacteria often show resistance to commonly used drugs such as fluoroquinolones.",[73],"Incidence of Infectious Diseases",[75,76],"Hematopoietic Cell Transplantation","Bloodstream Infections","2025-12-19",{"date":79,"type":80},"2025-12-29","ACTUAL",{"date":82,"type":80},"2024-09-01",{"date":84,"type":67},"2027-10-31",{"name":5,"class":6},1]