A Phase 3 interventional study of Piperacillin/Tazobactam and Ceftriaxone + Metronidazole in Appendicitis Perforated, Appendectomy, Laparoscopic and Antibiotic, sponsored by McMaster Children's Hospital. Not yet recruiting. Open to participants aged 0 Weeks to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by McMaster Children's Hospital · Phase 3, Interventional, and Treatment
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.
417 studies on the registry are indexed under Appendicitis; 63 are open to participants now.
This study's planned enrollment of 180 is above the median of 111 across 248 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →McMaster Children's Hospital is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Drug: Piperacillin/Tazobactam
Drug: Ceftriaxone + Metronidazole
Piperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily.
Drug pages: Ceftriaxone · Metronidazole
Ceftriaxone 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.
Time frame: Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days.
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.
Time frame: Within 30 days of surgery.
Number of participants requiring post-operative ultrasound
Number of participants who undergo at least one abdominal ultrasound following the index appendectomy.
Time frame: Within 30 days of surgery.
Number of participants undergoing percutaneous drain insertion
Number of participants who undergo percutaneous drain insertion by Interventional Radiology following the index appendectomy.
Time frame: Within 30 days of surgery.
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.
Time frame: Within 30 days of surgery.
Number of participants receiving parenteral nutrition
Number of participants who receive parenteral nutrition following the index appendectomy.
Time frame: Within 30 days of surgery.
Number of participants with Clostridioides difficile infection
Number of participants who develop laboratory-confirmed Clostridioides difficile infection requiring treatment following the index appendectomy.
Time frame: Within 30 days of surgery.
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.
Time frame: Within 30 days of surgery.
Number of participants readmitted to hospital
Number of participants who require hospital readmission following discharge from the index hospitalization for appendectomy.
Time frame: Within 30 days of surgery.
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.
Time frame: 30 days after surgery.
Health-related quality of life: generic
Assessed using the EuroQol 5D (EQ-5D) instrument.
Time frame: 30 days after surgery.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Apr 2027; primary completion for Dec 2031, 56 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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