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.
The study will include 180 children from several pediatric hospitals. After surgery, participants will be randomly assigned to receive either piperacillin/tazobactam (PT) or ceftriaxone plus metronidazole (CM). The child, family, healthcare team, and researchers assessing the outcomes will not know which treatment was received.
The 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.
Children 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.
The 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.
Laparoscopic appendectomy
Perforated appendicitis confirmed intra-operatively (i.e., visible hole in appendix, fecalith found in peritoneal cavity, intra-abdominal abscess, and/or purulent fluid in peritoneal cavity)
Non-operative treatment (e.g., due to abscess)
Interval laparoscopic appendectomy
Conversion to open procedure
Non-perforated appendicitis
Parallel
Piperacillin/Tazobactam
DrugPiperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily.
Ceftriaxone + Metronidazole
DrugCeftriaxone 50 mg/kg IV once daily (to a maximum of 2 g IV daily) and metronidazole 10 mg/kg IV q8h (to a maximum of 500 mg IV q8h).
Length of hospital stay
Length of stay in hospital during index admission.
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.
Number of participants requiring post-operative ultrasound
Number of participants who undergo at least one abdominal ultrasound following the index appendectomy.
Number of participants undergoing percutaneous drain insertion
Number of participants who undergo percutaneous drain insertion by Interventional Radiology following the index appendectomy.
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.
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.
Health-related quality of life: generic
Assessed using the EuroQol 5D (EQ-5D) instrument.
Click on the lead sponsor to view all of their trials.
McMaster Children's Hospital
Lead sponsor
Hamilton Health Sciences Corporation
Sponsor institution
Alberta Children's Hospital
Collaborator
Children's Hospital, London Health Sciences Center
Collaborator
Montreal Children's Hospital of the MUHC
Collaborator
The Hospital for Sick Children
Collaborator
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