Clinical Research Directory

Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis

Sponsor: McMaster Children's Hospital

Summary

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.

Official title: Assessing the Longitudinal Outcomes of Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis: A Multicentre Randomized Controlled Trial

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