[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659759":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":50,"studyPopulation":50,"armGroups":59,"interventions":70,"overallOfficials":50,"centralContacts":79,"locations":50,"responsibleParty":86,"collaborators":91,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":50,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":125,"overallStatus":130,"whyStopped":50,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":50},{"fullName":5,"class":6},"McMaster Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"Length of hospital stay","Length of stay in hospital during index admission.","Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days.",[14,18,21,24,27,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Number of participants with deep or organ-space surgical site infection","Number of participants who develop a deep incisional or organ-space surgical site infection following the index appendectomy.","Within 30 days of surgery.",{"measure":19,"description":20,"timeFrame":17},"Number of participants requiring post-operative ultrasound","Number of participants who undergo at least one abdominal ultrasound following the index appendectomy.",{"measure":22,"description":23,"timeFrame":17},"Number of participants undergoing percutaneous drain insertion","Number of participants who undergo percutaneous drain insertion by Interventional Radiology following the index appendectomy.",{"measure":25,"description":26,"timeFrame":17},"Number of participants undergoing peripherally inserted central catheter (PICC) insertion","Number of participants who undergo insertion of a peripherally inserted central catheter (PICC) following the index appendectomy.",{"measure":28,"description":29,"timeFrame":17},"Number of participants receiving parenteral nutrition","Number of participants who receive parenteral nutrition following the index appendectomy.",{"measure":31,"description":32,"timeFrame":17},"Number of participants with Clostridioides difficile infection","Number of participants who develop laboratory-confirmed Clostridioides difficile infection requiring treatment following the index appendectomy.",{"measure":34,"description":35,"timeFrame":17},"Number of participants returning to the emergency department","Number of participants who return to an emergency department following discharge from the index hospitalization for appendectomy.",{"measure":37,"description":38,"timeFrame":17},"Number of participants readmitted to hospital","Number of participants who require hospital readmission following discharge from the index hospitalization for appendectomy.",[40,44],{"measure":41,"description":42,"timeFrame":43},"Health-related quality of life: disease-specific","Time to return to school and unrestricted physical activity, reflecting recovery domains addressed in core outcome sets for pediatric appendicitis.","30 days after surgery.",{"measure":45,"description":46,"timeFrame":43},"Health-related quality of life: generic","Assessed using the EuroQol 5D (EQ-5D) instrument.",{"allocation":48,"interventionModel":49,"interventionModelDescription":50,"primaryPurpose":51,"observationalModel":50,"timePerspective":50,"maskingInfo":52},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":53,"maskingDescription":50,"whoMasked":54},"QUADRUPLE",[55,56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[60,65],{"label":61,"type":62,"description":50,"interventionNames":63},"Piperacillin\u002Ftazobactam","EXPERIMENTAL",[64],"Drug: Piperacillin\u002FTazobactam",{"label":66,"type":67,"description":50,"interventionNames":68},"Ceftriaxone + Metronidazole","ACTIVE_COMPARATOR",[69],"Drug: Ceftriaxone + Metronidazole",[71,76],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":50},"DRUG","Piperacillin\u002FTazobactam","Piperacillin\u002Ftazobactam 100 mg\u002Fkg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily.",[61],{"type":72,"name":66,"description":77,"armGroupLabels":78,"otherNames":50},"Ceftriaxone 50 mg\u002Fkg IV once daily (to a maximum of 2 g IV daily) and metronidazole 10 mg\u002Fkg IV q8h (to a maximum of 500 mg IV q8h).",[66],[80],{"name":81,"role":82,"phone":83,"phoneExt":84,"email":85},"Michael Livingston, MD, MSc, FRCSC","CONTACT","905-521-2100","75231","livingm@mcmaster.ca",{"type":87,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":90,"oldNameTitle":50,"oldOrganization":50},"PRINCIPAL_INVESTIGATOR","Michael Livingston","Associate Professor of Surgery","Hamilton Health Sciences Corporation",[92,94,97,99],{"name":93,"class":6},"Alberta Children's Hospital",{"name":95,"class":96},"Children's Hospital, London Health Sciences Center","UNKNOWN",{"name":98,"class":6},"Montreal Children's Hospital of the MUHC",{"name":100,"class":6},"The Hospital for Sick Children","100659759","phase-3-piperacillintazobactam-versus-ceftriaxone-and-metronidazole-for-children-with-perforated-appendicitis-100659759",false,"NCT07869095","Piperacillin\u002FTazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis","Assessing the Longitudinal Outcomes of Piperacillin\u002FTazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis: A Multicentre Randomized Controlled Trial","ALPACA-MC","Inclusion Criteria:\n\n* Laparoscopic appendectomy\n* Perforated appendicitis confirmed intra-operatively (i.e., visible hole in appendix, fecalith found in peritoneal cavity, intra-abdominal abscess, and\u002For purulent fluid in peritoneal cavity)\n\nExclusion Criteria:\n\n* Non-operative treatment (e.g., due to abscess)\n* Interval laparoscopic appendectomy\n* Conversion to open procedure\n* Non-perforated appendicitis\n* Confirmed or suspected allergy to penicillins or cephalosporins\n* Renal impairment","ALL","0 Weeks","17 Years",{"count":113,"type":114},180,"ESTIMATED","INTERVENTIONAL",[117],"PHASE3","The ALPACA-MC trial is a blinded, multicentre randomized controlled trial comparing two postoperative antibiotic treatments for children undergoing laparoscopic appendectomy for perforated appendicitis. Perforated appendicitis occurs when the appendix has developed a hole or has burst.\n\nThe study will include 180 children from several pediatric hospitals. After surgery, participants will be randomly assigned to receive either piperacillin\u002Ftazobactam (PT) or ceftriaxone plus metronidazole (CM). The child, family, healthcare team, and researchers assessing the outcomes will not know which treatment was received.\n\nThe main purpose of the study is to determine whether PT reduces hospital length of stay compared with CM. The study will also compare other important outcomes, including surgical site infections, the need for additional imaging or procedures, emergency department visits, and hospital readmissions.\n\nChildren will be followed for 30 days after surgery. At 30 days, families will be contacted to ask about any additional complications and how well the child has recovered. This will include questions about returning to school, sports or other physical activities, and the child's overall health and quality of life.\n\nThe results of this study will help determine which antibiotic treatment is most appropriate for children with perforated appendicitis and may help guide future clinical practice and antibiotic stewardship.",[120,121,122,123,124],"Appendicitis Perforated","Appendectomy, Laparoscopic","Antibiotic","Pediatric","Randomized Controlled Trial",[126,127,128,129],"Piperacillin","Tazobactam","Ceftriaxone","Metronidazole","NOT_YET_RECRUITING","2026-10-06",{"date":133,"type":134},"2026-10-09","ACTUAL",{"date":136,"type":114},"2027-04",{"date":138,"type":114},"2031-12",{"name":5,"class":6}]