[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vancomycin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vancomycin":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,46,79,100,125,158],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100637325","phase-1-novel-biomarkers-of-non-ige-immediate-hypersensitivity-drug-reactions-100637325",false,"NCT07605806","Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions","Inclusion Criteria:\n\n* Male or female age ≥ 18 years.\n* Adequate kidney function as defined by creatinine level within normal institutional limits at the participant's first visit.\n* Women of child bearing potential must agree to a reliable form of highly effective contraception (hormonal, device, or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 days following completion of vancomycin therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform the Principal Investigator and her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent.\n* Ability to clearly understand and speak English at an 8th grade reading level. For safety reasons, participants must speak English due to the anticipated need for clear and timely communication with investigators and the study team in emergency situations, since the investigators and study team are English speaking.\n\nExclusion Criteria:\n\n* Participants who have previously received vancomycin in any formulation, including oral or intravenous.\n* History of allergic reactions to study drug or reactions attributed to compounds of similar chemical or biologic composition to vancomycin, including active product or excipients.\n* Concurrent use of medications thought to cause non-specific mast cell activation (e.g. opioids)\n* Baseline serum tryptase over 8.0 ng\u002FmL and\u002For known mast cell disorder, including, but not limited to, mastocytosis, idiopathic mast cell activation syndrome, and hereditary alpha tryptasemia\n* Active infection or immunodeficiency\n* Unstable cardiovascular disease\n* Renal insufficiency\n* Current hearing deficit\n* Current use of beta-blockers\n* Use of immunomodulatory therapies or oral corticosteroids within the previous 1 month\n* Use of biologics in the previous 6 months, including omalizumab\n* Participants taking antihistamines must stop these drugs for one week prior to enrollment and must refrain from taking antihistamines during the duration of the study so as not to interfere with responses during drug challenge",true,"ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin. The main question it aims to answer is:\n\n• Identifying novel biomarkers in blood that occur during infusion reaction\n\nParticipants will:\n\n* Have allergy skin testing for vancomycin\n* Receive an infusion of vancomycin",[27,28,29],"Healthy Volunteer","Hypersensitivity Reactions","Vancomycin",[31,32,33],"non-IgE-mediated hypersensitivity reaction","Healthy volunteer","vancomycin","RECRUITING","2026-05-21",{"date":37,"type":38},"2026-05-26","ACTUAL",{"date":35,"type":20},{"date":41,"type":20},"2027-06-30",{"name":43,"class":44},"Johns Hopkins University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100548887","pediatric-antibiotic-dosing-in-extracorporal-membrane-oxygenation-padecmo-100548887","NCT06426836","Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation (PADECMO)","Pediatric Antibiotic Dosing in Extracorporal Membrane Oxygenation","PADECMO","Inclusion Criteria:\n\n* patients admitted to the pediatric intensive care unit or cardiac intensive care unit\n* patient age : 1,8 kg-15 years\n* patient receiving antibiotic treatment (piperacillin-tazobactam, meropenem, amoxicillin-clavulanate, cephazolin, vancomycin, teicoplanin, ciprofloxacin, amikacin)\n* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)\n* extracorporeal membrane oxygenation circuit\n\nExclusion Criteria:\n\n* no catheter in place for blood sampling\n* absence of parental\u002Fpatient consent\n* known hypersensitivity to beta-lactam antibiotics and ciprofloxacin","15 Years",{"count":56,"type":20},300,[58],"NA","Pharmacokinetics of antibiotics in critically ill neonates, infants and children on extracorporeal membrane oxygenation (ECMO).",[61,62,63,64,65,66,29,67,68],"Pharmacokinetics","Amoxicillin-clavulanate","Piperacillin-tazobactam","Meropenem","Cefazolin","Teicoplanin","Ciprofloxacin","Amikacin","2026-01-15",{"date":71,"type":38},"2026-01-16",{"date":73,"type":38},"2016-08-19",{"date":75,"type":20},"2026-07-01",{"name":77,"class":44},"University Hospital, Ghent",3,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":90,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":45},"100244176","antibiotic-dosing-in-pediatric-intensive-care-100244176","NCT02456974","Antibiotic Dosing in Pediatric Intensive Care","ADIC","Inclusion Criteria:\n\n* patients admitted to the pediatric intensive care unit\n* patient age\u002Fweight : 1,8 kg-15 years\n* patient receiving antibiotic treatment (piperacillin-tazobactam, amoxicillin-clavulanate, vancomycin, teicoplanin, meropenem, ciprofloxacin, amikacin) via intermittent infusion regimen or continuous infusion according to institutional treatment guidelines\n* intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred)\n\nExclusion Criteria:\n\n* no catheter in place for blood sampling\n* absence of parental\u002Fpatient consent\n* known hypersensitivity to beta-lactam antibiotics, glycopeptides, fluoroquinolones, aminoglycosides\n* extracorporeal circuit (haemodialysis, ECMO, peritoneal dialysis )","1 Day","16 Years",{"count":89,"type":20},640,"3 Days","OBSERVATIONAL","Pharmacokinetics of antibiotics in critically ill neonates, infants and children",[61,62,63,29,66,64,67,68],{"date":71,"type":38},{"date":96,"type":4},"2012-05",{"date":98,"type":20},"2027-09-01",{"name":77,"class":44},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":21,"phases":109,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":108},"100575468","vancomycin-reduction-practices-vrp-in-the-nicu-100575468","NCT06772675","Vancomycin Reduction Practices (VRP) in the NICU","Implementing Vancomycin Reducing Practices (VRP) in Preterm Infants","Inclusion Criteria:\n\n* Level III NICU\n* Affiliated with Kaiser Permanente Northern California (KPNC) or Children's Hospital of Philadelphia Newborn Care Network (CNBCN)\n* Recruited by study team\n\nExclusion Criteria:\n\n* Site not recruited for the study",{"count":108,"type":20},13,[58],"This multi-center, cluster randomized study aimed at improving implementation of vancomycin reducing practices (VRP) in neonatal intensive care units (NICUs). Sites will be recruited and randomized to receive either external facilitation or no external facilitation to assess the effect on center-level fidelity to the core components of VRP implementation. Interventions available to both study arms are directed at hospital staff and includes identification of local champions, educational outreach, unit-level audit \\& feedback, and use of a clinical decision support tool.",[112,113,29],"Antibiotic Stewardship","Neonatal Sepsis, Late-Onset",[115],"implementation study","2025-12-18",{"date":118,"type":38},"2025-12-24",{"date":120,"type":38},"2025-06-02",{"date":122,"type":20},"2027-09",{"name":124,"class":44},"Children's Hospital of Philadelphia",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":143,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100602206","stop-cdi-efficacy-of-fecal-microbiota-transplantation-vs-fidaxomicin-vs-vancomycin-in-treating-and-preventing-relapse-of-clostridioides-difficile-infection-100602206","NCT07120490","STOP-CDI: Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in Treating and Preventing Relapse of Clostridioides Difficile Infection","Multicenter, Randomized, Open-label, Three-arm Study on the Efficacy of Fecal Microbiota Transplantation vs Fidaxomicin vs Vancomycin in the Treatment and Relapse Prophylaxis of Clostridioides Difficile Infection. STOP-CDI Study","STOP-CDI","Inclusion Criteria:\n\n* Individuals aged 65 years or older OR individuals aged 18 to 64 years who meet at least one of the following criteria:\n* Presence of at least two comorbid chronic diseases from the groups of cardiovascular diseases, respiratory system diseases, gastrointestinal diseases, autoimmune diseases, cancers, chronic kidney and genitourinary diseases, immunodeficiencies, diabetes, and metabolic diseases,\n* Previous episodes of CDI,\n* Healthcare-associated CDI and\u002For hospitalization within the last three months,\n* Concurrent use of antibiotics other than CDI treatment after CDI diagnosis,\n* Use of proton pump inhibitors (PPIs) started during or after CDI diagnosis.\n* Documented Clostridioides difficile infection, defined according to ESCMID as:\n\nDiagnosis of diarrhea associated with C. difficile defined by:\n\n* \\> 3 unformed stools (or \\>200 ml of unformed stool in patients with stool collection devices) within 24 hours before randomization AND\n* Clinical signs consistent with CDI and microbiological evidence of free C. difficile toxins in an enzyme immunoassay (EIA) without justified evidence of another cause of diarrhea OR\n* Clinical picture consistent with CDI and positive nucleic acid amplification test (NAAT; PCR) preferably with low cycle threshold (Ct) value, or positive toxigenic C. difficile culture OR\n* Pseudomembranous colitis diagnosed during endoscopy or colectomy combined with a positive test for toxigenic C. difficile.\n* No more than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin.\n* Absolute neutrophil count in peripheral blood within 3 days before intervention \\> 500\u002Fµl.\n* Ability to swallow large capsules (using test capsules) or no contraindications for FMT via nasojejunal tube, gastroscopy, colonoscopy, or rectal enema.\n* Provided informed consent for participation in the clinical study.\n\nExclusion Criteria:\n\n* Lack of consent to participate in the study or absence of logical contact without possibility of obtaining consent from an authorized person,\n* More than 24 hours of prior treatment with vancomycin, metronidazole, or fidaxomicin,\n* On the day of inclusion (up to 3 days before starting intervention) absolute neutrophil count in blood \\\u003C500 cells\u002Fµl or expected drop to this level within the next 2 days,\n* Diagnosed HIV infection with CD4 lymphocyte count \\\u003C250 cells\u002Fµl,\n* Inability to swallow large capsules (failed test capsule use) or contraindications for FMT via upper or lower gastrointestinal tract, including gastrointestinal perforation, anal atresia, discontinuity of the gastrointestinal tract, and others,\n* Known presence of other pathogens in stool known to cause diarrhea,\n* Life expectancy \\\u003C3 months,\n* Life-threatening CDI (fulminant at diagnosis - especially with septic shock),\n* Total or subtotal colectomy, ileostomy, or colostomy,\n* Unwillingness or inability to comply with protocol requirements, including any condition (physical, mental, or social) that may affect the participant's ability to adhere to the protocol.",{"count":134,"type":20},424,[58],"The STOP-CDI study is a multicenter, randomized, open-label, three-arm clinical trial comparing the efficacy of fecal microbiota transplantation (FMT) preceded by vancomycin, fidaxomicin monotherapy, and standard-of-care vancomycin in preventing recurrence of Clostridioides difficile infection (CDI) in high-risk adult patients.\n\nCDI is a common healthcare-associated infection with rising incidence and high recurrence rates, particularly in elderly and immunocompromised individuals. While current guidelines recommend fidaxomicin as first-line therapy, its availability and reimbursement remain limited in some healthcare systems. FMT, although effective, is not widely implemented as first-line treatment. This study addresses the need for comparative, real-world data to inform treatment decisions for patients at high risk of severe or recurrent CDI.\n\nEligible participants include adults aged ≥65 years or younger patients with specific risk factors such as multiple comorbidities, prior CDI episodes, recent hospitalization, use of non-CDI antibiotics, or PPI therapy. Participants will be randomized in a 2:1:1 ratio to one of three treatment arms: (1) vancomycin plus FMT, (2) fidaxomicin, or (3) vancomycin alone. FMT is administered via capsules or, if necessary, alternative endoscopic routes.\n\nThe primary endpoint is CDI recurrence within 12 weeks following the initial treatment. Secondary endpoints include clinical cure, safety, and global cure. Exploratory analyses will assess microbiome changes and potential genomic predictors of response. A total of 424 participants will be enrolled across 10 clinical sites in Poland.\n\nThe study aims to provide robust, comparative evidence to support clinical guidelines and improve outcomes for patients with CDI, particularly in healthcare systems with limited access to novel therapies.",[138,139,140,141,142,29],"Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","Fecal Microbiota Transplantation (FMT)","Comparative Effectiveness of CDI Treatments","Fidaxomicin",[144,145,146,142,29,147],"Clostridioides difficile","CDI","Fecal microbiota transplantation","Recurrent infection","NOT_YET_RECRUITING","2025-08-06",{"date":151,"type":38},"2025-08-13",{"date":153,"type":20},"2025-10",{"date":155,"type":20},"2027-04-30",{"name":157,"class":44},"Medical University of Warsaw",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":4,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":4},"100513334","first-time-right-of-vancomycin-100513334","NCT05964114","First Time Right of Vancomycin","Prospective Individualization of the First Vancomycin Dose Using Population Pharmacokinetic Models.","Inclusion Criteria:\n\n* Adult patients who receive continuous vancomycin treatment at the ICU or orthopaedic department\n* Patient or their legal representative is able and willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Pregnant woman\n* Children\n* Patients with a transplantation history\n* Patients on continuous renal replacement therapy (CRRT)\n* Patients receiving extracorporeal membrane oxygenation (ECMO)",{"count":166,"type":20},134,[58],"In 2020, only 16% of the Intensive Care Unit (ICU) patients achieved therapeutic drug concentrations after continuous administration of the first vancomycin dose. Many beneficial population pharmacokinetic (PPK) models are available however these are prevented from being widely implemented in daily practice due to the complexity. The aim of this study is to evaluate the effectiveness of individualized dosing with PPK models using a newly developed user-friendly pharmacokinetic (PK) tool.\n\nIn a preceding retrospective study, the percentage of patients within the target range after initiation of continuous vancomycin increased from 28% to 39% (excluding CRRT and ECMO patients) with calculated concentrations based on theoretical dose adjustments. In this study we want to prospectively evaluate the concentration of vancomycin at 24, 28 and 72 hours after the start of treatment with individualized dosages based on (a combination) of available PPK models in 134 adult ICU and orthopedic patients.",[29,61],"2023-07-19",{"date":172,"type":38},"2023-07-27",{"date":174,"type":20},"2023-10",{"date":176,"type":20},"2026-06",{"name":178,"class":44},"Erasmus Medical Center"]