Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Phase 4

Completed

• Conditions: Perforated Appendicitis; Postoperative Infection
• Interventions: Drug: Piperacillin, Tazobactam Drug Combination

• Registration Number: NCT03289351
• Lead Sponsor: Phoenix Children's Hospital

Brief Summary

After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

Detailed Description

The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

Study Timeline

• Study Start: 2017-05-22
• Study First Submitted: 2017-09-18
• Study First Submitted QC: 2017-09-18
• Study First Posted: 2017-09-20
• Primary Completion: 2021-11-17
• Status Verified: 2023-03
• Study Completion: 2023-11-07
• Results First Submitted: 2023-11-13
• Results First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Results First Posted: 2024-01-12
• Last Update Posted: 2024-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

• Postoperative Perforated Appendicitis (documented by intraoperative photo)
• Postoperative Laparoscopic Appendectomy

Exclusion Criteria

• Nonperforated Gangrenous Appendicitis
• Nonperforated Purulent Appendicitis
• Open Appendectomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-drug Therapy	Piperacillin, Tazobactam Drug Combination	piperacillin-tazobactam

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Postoperative Intra-abdominal Abscess	30 days	Intra-abdominal abscess documented by ultrasound or computerized tomography

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Surgical Site Infection	30 days	surgical site infections including superficial port site infection
Number of Participants With a Postoperative Readmission	30 days	readmission within 30 days for any gastrointestinal complaints or infectious complications

Trial Locations

Locations (2)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States