[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630204":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":60,"locations":66,"responsibleParty":87,"collaborators":31,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":91,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":31,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":31,"overallStatus":113,"whyStopped":31,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"pediatric patients, short-term infusion (P, SI) and neonatal patients, short-term infusion (N, SI)","ACTIVE_COMPARATOR","subset P: 28 days - 17 years subset N: term or pre-term infants \\\u003C 28 days of post-natal age, or PMA\\* \\\u003C 44 weeks\n\n\\*postmenstrual age",[13,14,15,16],"Drug: Short-term infusion time of the following beta-lactam: meropenem","Drug: Short-term infusion time of the following beta-lactam: piperacillin\u002Ftazobactam","Drug: Short-term infusion time of the following beta-lactam: cefepime","Drug: Short-term infusion time of the following beta-lactam: ceftriaxone",{"label":18,"type":19,"description":11,"interventionNames":20},"pediatric patients, extended infusion (P, EI) and neonatal patients, extended infusion (N, EI)","EXPERIMENTAL",[21,22,23,24],"Drug: Extended infusion time of the following beta-lactam: meropenem","Drug: Extended infusion time of the following beta-lactam: piperacillin\u002Ftazobactam","Drug: Extended infusion time of the following beta-lactam: cefepime","Drug: Extended infusion time of the following beta-lactam: ceftriaxone",[26,32,36,40,44,48,52,56],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Extended infusion time of the following beta-lactam: meropenem","Group extended infusion (EI):\n\nDuration of infusion is 3 hours (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- meropenem (MPM): 30 mg\u002Fkg or 40 mg\u002Fkg for meningitis q8h (max. 2 g q8h)\n\nSubset neonatal (N):\n\nThe doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[18],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Short-term infusion time of the following beta-lactam: meropenem","Group short-term infusion (SI):\n\nDuration of infusion is 0.5 hour (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- meropenem (MPM): 30 mg\u002Fkg or 40 mg\u002Fkg for meningitis q8h (max. 2 g q8h)\n\nSubset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[9],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Extended infusion time of the following beta-lactam: piperacillin\u002Ftazobactam","Group extended infusion (EI):\n\nDuration of infusion is 3 hours (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- piperacillin\u002Ftazobactam (TZP): 90 mg\u002Fkg piperacillin q6h for non-immunosuppressed patients and 100 mg\u002Fkg piperacillin q6h for immunosuppressed patients (max. 4.5 g piperacillin\u002Ftazobactam per dose)\n\nSubset neonatal (N):\n\nThe doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[18],{"type":27,"name":41,"description":42,"armGroupLabels":43,"otherNames":31},"Extended infusion time of the following beta-lactam: cefepime","Group extended infusion (EI):\n\nDuration of infusion is 3 hours (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- cefepime (CFP): 30-50 mg\u002Fkg q8h or q12h (\\>1 month: 30 mg\u002Fkg every 8-12 hours, 2 months-17 years (bodyweight up to 41 kg): 50 mg\u002Fkg every 8-12 hours (max. 2 g per dose; increased dose \\[q8h\\] used for severe infection and febrile neutropenia)\n\nSubset neonatal (N):\n\nThe doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[18],{"type":27,"name":45,"description":46,"armGroupLabels":47,"otherNames":31},"Extended infusion time of the following beta-lactam: ceftriaxone","Group extended infusion (EI):\n\nDuration of infusion is 3 hours (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- ceftriaxone (CTX): 50 mg\u002Fkg q12h (max. 4 g per day)\n\nSubset neonatal (N):\n\nThe doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[18],{"type":27,"name":49,"description":50,"armGroupLabels":51,"otherNames":31},"Short-term infusion time of the following beta-lactam: piperacillin\u002Ftazobactam","Group short-term infusion (SI):\n\nDuration of infusion is 0.5 hour (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- piperacillin\u002Ftazobactam (TZP): 90 mg\u002Fkg piperacillin q6h for non-immunosuppressed patients and 100 mg\u002Fkg piperacillin q6h for immunosuppressed patients (max. 4.5 g piperacillin\u002Ftazobactam per dose)\n\nSubset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[9],{"type":27,"name":53,"description":54,"armGroupLabels":55,"otherNames":31},"Short-term infusion time of the following beta-lactam: cefepime","Group short-term infusion (SI):\n\nDuration of infusion is 0.5 hour (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- cefepime (CFP): 30-50 mg\u002Fkg q8h or q12h (\\>1 month: 30 mg\u002Fkg every 8-12 hours, 2 months-17 years (bodyweight up to 41 kg): 50 mg\u002Fkg every 8-12 hours (max. 2 g per dose; increased dose \\[q8h\\] used for severe infection and febrile neutropenia)\n\nSubset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[9],{"type":27,"name":57,"description":58,"armGroupLabels":59,"otherNames":31},"Short-term infusion time of the following beta-lactam: ceftriaxone","Group short-term infusion (SI):\n\nDuration of infusion is 0.5 hour (h)\n\nSubset paediatric (P):\n\nThe doses of beta-lactams are (q…h= every…hours):\n\n\\- ceftriaxone (CTX): 50 mg\u002Fkg q12h (max. 4 g per day)\n\nSubset neonatal (N): The doses of beta-lactams are as recommended by NeoFax® (MerativeTM Micromedex® database), based on postmenstrual age (PMA) and postnatal age.",[9],[61],{"name":62,"role":63,"phone":64,"phoneExt":31,"email":65},"Kinga Anna Budai","CONTACT","+36206632915","budai.kinga@semmelweis.hu",[67,81],{"facility":68,"status":31,"city":69,"state":31,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Pediatric Center (Bókay Street Department), Semmelweis University","Budapest","1083","Hungary","HU",{"type":74,"coordinates":75},"Point",[76,77],19.04045,47.49835,{"lat":77,"lon":76},[80],{"name":62,"role":63,"phone":64,"phoneExt":31,"email":65},{"facility":82,"status":31,"city":69,"state":31,"zip":83,"country":71,"countryCode":72,"cosmosGeoPoint":84,"geoPoint":86,"contacts":31},"Pediatric Center (Tűzoltó Street Department), Semmelweis University","1094",{"type":74,"coordinates":85},[76,77],{"lat":77,"lon":76},{"type":88,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100630204","phase-4-a-study-to-compare-the-efficacy-and-safety-of-extended-and-intermittent-infusion-of-beta-lactams-in-critically-ill-paediatric-patients-100630204",false,"NCT07484633","A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","A Protocol of a Randomised, Two-arm Superiority Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients","PEBBLE","Inclusion Criteria:\n\n* paediatric patients (0-17 years of age) with suspected or confirmed bacterial infection who are treated in a PICU or NICU and diagnosed with sepsis with a total Phoenix Sepsis Score ≥2 points, and the infection is clinically probable or confirmed by microbiological culture (e.g. from a blood culture, cerebrospinal fluid, urine, trachea, wound, etc.), excluding contamination;\n* who are receiving β-lactams including meropenem, piperacillin\u002Ftazobactam, cefepime and ceftriaxone;\n* who received the same β-lactam therapy within 24 hours prior to inclusion or started new β-lactam therapy due to clinical deterioration;\n* written consent of the parent or guardian is obtained.\n\nExclusion Criteria:\n\n* palliative care patients;\n* patients participating in other drug trials;\n* patients with impaired renal function if dosing modification is required (estimated Glomerular Filtration Rate \\[eGFR\\]\\\u003C50 mL\u002Fmin\u002F1.73m2 for meropenem, cefepime, and piperacillin\u002Ftazobactam; eGFR\\\u003C10 mL\u002Fmin\u002F1.73m2 for ceftriaxone);\n* patients undergoing plasmapheresis (TPE);\n* patients undergoing extracorporeal therapy (continuous kidney replacement therapy \\[CKRT\\] or extracorporeal membrane oxygenation \\[ECMO\\]);\n* β-lactam allergy;\n* patients admitted from another institution or department who have been on the same β-lactam treatment for more than 24 hours;\n* pregnancy.","ALL","0 Hours","17 Years",{"count":101,"type":102},110,"ESTIMATED","INTERVENTIONAL",[105],"PHASE4","The goal of this clinical trial is to examine the success and safety of administering certain antibiotics (beta-lactams) given in a longer 3-hour infusion to children (0-17 years) who are critically ill and have severe infection.\n\nThe main question it aims to answer is:\n\nIs the longer infusion more effective than the conventional short-term (0.5-hour-long) infusion? Researchers will compare the 3-hour-long infusion group to the 0.5-hour-long infusion group to determine whether the longer infusion can cure the infection earlier and whether it is equally safe. The doses are the same in the two groups. Only the duration differs until the patient receives the antibiotic.\n\nParticipants will:\n\n* be given the required antibiotic drug in a 3-hour-long or in a 0.5 hour-long infusion.\n* be examined to make sure their blood drug levels are correct. This will require two blood tests.\n* be treated according to routine care and have examinations and blood tests performed.",[108,109,110,111,112],"Infection","Sepsis","NICU","PICU","Beta Lactams","NOT_YET_RECRUITING","2026-04-07",{"date":116,"type":117},"2026-04-13","ACTUAL",{"date":119,"type":102},"2026-04",{"date":121,"type":102},"2028-04",{"name":5,"class":6},2]