NCT05943223

Brief Summary

This study is an internal pilot for a multicenter, blinded randomized controlled trial. The purpose of the multicenter trial is to determine whether post-operative piperacillin/tazobactam is more effective than ceftriaxone and metronidazole for children treated with laparoscopic appendectomy for perforated appendicitis. We plan to conduct an internal pilot study to determine whether a blinded multicenter randomized controlled trial is feasible.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2024

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 13, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

June 26, 2023

Last Update Submit

July 4, 2023

Conditions

Appendicitis Perforated

Keywords

ChildPiperacillinCeftriaxoneMetronidazole

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Length of stay in hospital during index admission

    Index admission

Secondary Outcomes (10)

  • Percutaneous drain insertion

    Within 30 days of surgery

  • Deep or organ-space surgical site infection

    Within 30 days of surgery

  • Insertion of Peripherally Inserted Central Catheter (PICC)

    Within 30 days of surgery

  • Parenteral nutrition

    Within 30 days of surgery

  • Post-operative ultrasound

    Within 30 days of surgery

  • +5 more secondary outcomes

Other Outcomes (5)

  • Recruitment rate

    Through study completion (average of 1 year)

  • Consent rate

    Through study completion (average of 1 year)

  • Rate of protocol violations

    Through study completion (average of 1 year)

  • +2 more other outcomes

Study Arms (2)

Piperacillin/tazobactam

EXPERIMENTAL
Drug: Piperacillin/tazobactamDrug: Normal saline

Ceftriaxone and metronidazole

ACTIVE COMPARATOR
Drug: CefTRIAXone InjectionDrug: Metronidazole Injection

Interventions

Piperacillin/tazobactamDRUG

Post-operative piperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h)

Piperacillin/tazobactam
Normal salineDRUG

Post-operative normal saline 50 mL once daily

Piperacillin/tazobactam
CefTRIAXone InjectionDRUG

Post-operative ceftriaxone 50 mg/kg IV once daily (to a maximum of 2 g IV once daily)

Ceftriaxone and metronidazole
Metronidazole InjectionDRUG

Post-operative metronidazole 10 mg/kg IV q8h (to a maximum of 500 mg IV q8h)

Ceftriaxone and metronidazole

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • St 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.

    PMID: 27521710BACKGROUND

  • Linnaus 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.

    PMID: 27989365BACKGROUND

  • St Peter SD, Tsao K, Spilde TL, Holcomb GW 3rd, Sharp SW, Murphy JP, Snyder CL, Sharp RJ, Andrews WS, Ostlie DJ. Single daily dosing ceftriaxone and metronidazole vs standard triple antibiotic regimen for perforated appendicitis in children: a prospective randomized trial. J Pediatr Surg. 2008 Jun;43(6):981-5. doi: 10.1016/j.jpedsurg.2008.02.018.

    PMID: 18558169BACKGROUND

  • Lee 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.

    PMID: 34132703BACKGROUND

  • Kashtan 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.

    PMID: 34876294BACKGROUND

  • Gerber JS, Jackson MA, Tamma PD, Zaoutis TE; COMMITTEE ON INFECTIOUS DISEASES, PEDIATRIC INFECTIOUS DISEASES SOCIETY. Antibiotic Stewardship in Pediatrics. Pediatrics. 2021 Jan;147(1):e2020040295. doi: 10.1542/peds.2020-040295.

    PMID: 33372120BACKGROUND

  • 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.

    PMID: 41202087DERIVED

MeSH Terms

Conditions

Appendicitis

Interventions

Piperacillin, Tazobactam Drug CombinationSaline SolutionCeftriaxoneMetronidazole

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical PreparationsCrystalloid SolutionsIsotonic SolutionsSolutionsCefotaximeCephacetrileCephalosporinsThiazinesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Michael H Livingston, MD, MSc

    McMaster Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Briatico, MSc

CONTACT

9055212100briaticd@mcmaster.ca

Michael H Livingston, MD, MSc

CONTACT

9055212100livingm@mcmaster.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Internal pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Surgeon

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 13, 2023

Study Start

January 1, 2024

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share