Appendicitis PerforatedPhase 3ALPACA-MCNCT07869095
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
A Phase 3 study testing Piperacillin/Tazobactam and Ceftriaxone + Metronidazole in people with Appendicitis Perforated and Appendectomy, Laparoscopic, run by McMaster Children's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 weeks to 17 years
- Conditions the study is for
- Appendicitis Perforated, Appendectomy, Laparoscopic, Antibiotic
- What is being tested?
- Piperacillin/Tazobactam and Ceftriaxone + Metronidazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Apr 2027to Dec 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Non-operative treatment (e.g., due to abscess)
- Interval laparoscopic appendectomy
- Conversion to open procedure
- Non-perforated appendicitis
- Confirmed or suspected allergy to penicillins or cephalosporins
- Renal impairment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Longitudinal Outcomes of Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis: A Multicentre Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Appendicitis Perforated, Appendectomy, Laparoscopic, Antibiotic, Pediatric, Randomized Controlled Trial
- Being tested
- Piperacillin/Tazobactam, Ceftriaxone + Metronidazole
- Keywords
- Piperacillin, Tazobactam, Ceftriaxone, Metronidazole
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piperacillin/TazobactamDrug
Piperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily.
Ceftriaxone + MetronidazoleDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Piperacillin/tazobactam | Experimental | Not described Receives: Drug: Piperacillin/Tazobactam |
| Ceftriaxone + Metronidazole | Active comparator | Not described Receives: Drug: Ceftriaxone + Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Length of stay in hospital during index admission.
Measured: Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days of surgery.
Number of participants receiving parenteral nutrition
Number of participants who receive parenteral nutrition following the index appendectomy.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 30 days of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startApr 2027 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Appendicitis PerforatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Children's Hospital, Children's Hospital, London Health Sciences Center, Montreal Children's Hospital of the MUHC, The Hospital for Sick Children
- Responsible party
- Principal investigator, Michael Livingston, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869095
- Sponsor's protocol ID
- HHS-582929
- Acronym
- ALPACA-MC
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Briatico D, Safa N, Flageole H, Khan S, Pernica J, Eltorki M, Cohen E, Livingston MH. Assessing the Longitudinal outcomes of Piperacillin/tazobactam versus ceftriAxone and metronidazole for Children with perforated Appendicitis (ALPACA): A protocol for a pilot randomized controlled trial. PLoS One. 2025 Nov 7;20(11):e0335991. doi: 10.1371/journal.pone.0335991. eCollection 2025.
PubMed 41202087Armstrong J, Sriranjan J, Briatico D, Khan S, Eltorki M, Livingston MH. Piperacillin/tazobactam versus ceftriaxone/metronidazole for children with perforated appendicitis: a systematic review and meta-analysis. Pediatr Surg Int. 2025 Nov 4;42(1):3. doi: 10.1007/s00383-025-06227-z.
PubMed 41186640Zeineddin S, Pitt JB, Linton S, De Boer C, Hu A, Carter M, Alayleh A, Abdullah F, Raval M, Goldstein SD. Postoperative Antibiotics for Complicated Appendicitis in Children: Piperacillin/Tazobactam Versus Ceftriaxone with Metronidazole. J Pediatr Surg. 2023 Jun;58(6):1128-1132. doi: 10.1016/j.jpedsurg.2023.02.027. Epub 2023 Feb 17.
PubMed 36931937Cramm SL, Graham DA, Feng C, Allukian M, Blakely ML, Chandler NM, Cowles RA, Kunisaki SM, Lipskar AM, Russell RT, Santore MT, Campbell BT, Commander SJ, DeFazio JR, Dukleska K, Echols JC, Esparaz JR, Gerall C, Griggs CL, Hanna DN, He K, Keane OA, McLean SE, Pace E, Scholz S, Sferra SR, Tracy ET, Zhang L, Rangel SJ; Eastern Pediatric Surgery Network. Use of Antipseudomonal Antibiotics is Not Associated With Lower Rates of Postoperative Drainage Procedures or More Favorable Culture Profiles in Children With Complicated Appendicitis: Results From a Multicenter Regional Research Consortium. Ann Surg. 2024 Jun 1;279(6):1070-1076. doi: 10.1097/SLA.0000000000006152. Epub 2023 Nov 16.
PubMed 37970676Kashtan MA, Graham DA, Melvin P, Hills-Dunlap JL, Anandalwar SP, Rangel SJ. Ceftriaxone with Metronidazole versus Piperacillin/Tazobactam in the management of complicated appendicitis in children: Results from a multicenter pediatric NSQIP analysis. J Pediatr Surg. 2022 Oct;57(10):365-372. doi: 10.1016/j.jpedsurg.2021.11.009. Epub 2021 Nov 20.
PubMed 34876294Lee J, Garvey EM, Bundrant N, Hargis-Villanueva A, Kang P, Osuchukwu O, Dekonenko C, Svetanoff WJ, St Peter SD, Padilla B, Ostlie D. IMPPACT (Intravenous Monotherapy for Postoperative Perforated Appendicitis in Children Trial): Randomized Clinical Trial of Monotherapy Versus Multi-drug Antibiotic Therapy. Ann Surg. 2021 Sep 1;274(3):406-410. doi: 10.1097/SLA.0000000000005006.
PubMed 34132703Linnaus ME, Ostlie DJ. Complications in common general pediatric surgery procedures. Semin Pediatr Surg. 2016 Dec;25(6):404-411. doi: 10.1053/j.sempedsurg.2016.10.002. Epub 2016 Oct 29.
PubMed 27989365St Peter SD, Snyder CL. Operative management of appendicitis. Semin Pediatr Surg. 2016 Aug;25(4):208-11. doi: 10.1053/j.sempedsurg.2016.05.003. Epub 2016 May 10.
PubMed 27521710
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Longitudinal Outcomes of Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis: A Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07869095
- Acronym / sponsor ID
- ALPACA-MC / HHS-582929
- Conditions
- Appendicitis Perforated, Appendectomy, Laparoscopic, Antibiotic, Pediatric, Randomized Controlled Trial
- Keywords
- Piperacillin, Tazobactam, Ceftriaxone, Metronidazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Collaborators
- Alberta Children's Hospital, Children's Hospital, London Health Sciences Center, Montreal Children's Hospital of the MUHC, The Hospital for Sick Children
- Study start
- Apr 2027 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piperacillin/tazobactam | Experimental | Drug: Piperacillin/Tazobactam |
| Ceftriaxone + Metronidazole | Active comparator | Drug: Ceftriaxone + Metronidazole |
Who may qualify
- Ages
- 0 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- Non-operative treatment (e.g., due to abscess)
- Interval laparoscopic appendectomy
- Conversion to open procedure
- Non-perforated appendicitis
- Confirmed or suspected allergy to penicillins or cephalosporins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piperacillin/TazobactamPiperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily. | Drug | Piperacillin/tazobactam |
| Ceftriaxone + MetronidazoleCeftriaxone 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). | Drug | Ceftriaxone + Metronidazole |
Primary outcome
Length of hospital stay
Time frame: Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days.
Length of stay in hospital during index admission.
8 secondary outcomes
Number of participants with deep or organ-space surgical site infection
Time frame: Within 30 days of surgery.
Number of participants requiring post-operative ultrasound
Time frame: Within 30 days of surgery.
Number of participants undergoing percutaneous drain insertion
Time frame: Within 30 days of surgery.
Number of participants undergoing peripherally inserted central catheter (PICC) insertion
Time frame: Within 30 days of surgery.
Number of participants receiving parenteral nutrition
Time frame: Within 30 days of surgery.
Number of participants with Clostridioides difficile infection
Time frame: Within 30 days of surgery.
Number of participants returning to the emergency department
Time frame: Within 30 days of surgery.
Number of participants readmitted to hospital
Time frame: Within 30 days of surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 41202087Briatico D, Safa N, Flageole H, Khan S, Pernica J, Eltorki M, Cohen E, Livingston MH. Assessing the Longitudinal outcomes of Piperacillin/tazobactam versus ceftriAxone and metronidazole for Children with perforated Appendicitis (ALPACA): A protocol for a pilot randomized controlled trial. PLoS One. 2025 Nov 7;20(11):e0335991. doi: 10.1371/journal.pone.0335991. eCollection 2025.
- Background: PubMed 41186640Armstrong J, Sriranjan J, Briatico D, Khan S, Eltorki M, Livingston MH. Piperacillin/tazobactam versus ceftriaxone/metronidazole for children with perforated appendicitis: a systematic review and meta-analysis. Pediatr Surg Int. 2025 Nov 4;42(1):3. doi: 10.1007/s00383-025-06227-z.
- Background: PubMed 36931937Zeineddin S, Pitt JB, Linton S, De Boer C, Hu A, Carter M, Alayleh A, Abdullah F, Raval M, Goldstein SD. Postoperative Antibiotics for Complicated Appendicitis in Children: Piperacillin/Tazobactam Versus Ceftriaxone with Metronidazole. J Pediatr Surg. 2023 Jun;58(6):1128-1132. doi: 10.1016/j.jpedsurg.2023.02.027. Epub 2023 Feb 17.
- Background: PubMed 37970676Cramm SL, Graham DA, Feng C, Allukian M, Blakely ML, Chandler NM, Cowles RA, Kunisaki SM, Lipskar AM, Russell RT, Santore MT, Campbell BT, Commander SJ, DeFazio JR, Dukleska K, Echols JC, Esparaz JR, Gerall C, Griggs CL, Hanna DN, He K, Keane OA, McLean SE, Pace E, Scholz S, Sferra SR, Tracy ET, Zhang L, Rangel SJ; Eastern Pediatric Surgery Network. Use of Antipseudomonal Antibiotics is Not Associated With Lower Rates of Postoperative Drainage Procedures or More Favorable Culture Profiles in Children With Complicated Appendicitis: Results From a Multicenter Regional Research Consortium. Ann Surg. 2024 Jun 1;279(6):1070-1076. doi: 10.1097/SLA.0000000000006152. Epub 2023 Nov 16.
- Background: PubMed 34876294Kashtan MA, Graham DA, Melvin P, Hills-Dunlap JL, Anandalwar SP, Rangel SJ. Ceftriaxone with Metronidazole versus Piperacillin/Tazobactam in the management of complicated appendicitis in children: Results from a multicenter pediatric NSQIP analysis. J Pediatr Surg. 2022 Oct;57(10):365-372. doi: 10.1016/j.jpedsurg.2021.11.009. Epub 2021 Nov 20.
- Background: PubMed 34132703Lee J, Garvey EM, Bundrant N, Hargis-Villanueva A, Kang P, Osuchukwu O, Dekonenko C, Svetanoff WJ, St Peter SD, Padilla B, Ostlie D. IMPPACT (Intravenous Monotherapy for Postoperative Perforated Appendicitis in Children Trial): Randomized Clinical Trial of Monotherapy Versus Multi-drug Antibiotic Therapy. Ann Surg. 2021 Sep 1;274(3):406-410. doi: 10.1097/SLA.0000000000005006.
- Background: PubMed 27989365Linnaus ME, Ostlie DJ. Complications in common general pediatric surgery procedures. Semin Pediatr Surg. 2016 Dec;25(6):404-411. doi: 10.1053/j.sempedsurg.2016.10.002. Epub 2016 Oct 29.
- Background: PubMed 27521710St Peter SD, Snyder CL. Operative management of appendicitis. Semin Pediatr Surg. 2016 Aug;25(4):208-11. doi: 10.1053/j.sempedsurg.2016.05.003. Epub 2016 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Piperacillin/Tazobactam and Ceftriaxone + Metronidazole in people with Appendicitis Perforated and Appendectomy, Laparoscopic, run by McMaster Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Livingston, MD, MSc, FRCSC (905-521-2100 ext. 75231, livingm@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07869095, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.