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ALPACA: Piperacillin/Tazobactam vs Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
NCT05943223Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2024
- Primary completion
- Jul 2025
- Countries
- 1
- Sponsor
- McMaster Children's Hospital
- Modality
- Irreversible Covalent Inhibitors
- Conditions
- appendicitis
01
Overview
Phase 2, randomised, double-blind trial of piperacillin + tazobactam in appendicitis (2 arms), sponsored by McMaster Children's Hospital. Primary endpoint: Length of stay. Started Sep 2024; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Piperacillin/tazobactam
Post-operative piperacillin/tazobactam 100 mg/kg IV q8h + normal saline 50 mL once daily
Ceftriaxone and metronidazole
Post-operative ceftriaxone 50 mg/kg IV once daily + metronidazole 10 mg/kg IV q8h
03
Who it enrols
Children undergoing laparoscopic appendectomy with intra-operatively confirmed perforated appendicitis, excluding those with non-operative treatment, interval appendectomy, conversion to open procedure, non-perforated appendicitis, allergy to penicillins or cephalosporins, or renal impairment.
04
Endpoints
Primary
Length of stay
Secondary
Percutaneous drain insertion
Deep or organ-space surgical site infection
Insertion of Peripherally Inserted Central Catheter (PICC)
Parenteral nutrition
Post-operative ultrasound
Clostridium difficile infection
Return to the emergency department
Readmission to hospital
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