Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

NCT ID: NCT03289351

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2023-11-07

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.

Conditions

Perforated Appendicitis; Postoperative Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2-drug Therapy

ceftriaxone/metronidazole

Group Type: NO_INTERVENTION

No interventions assigned to this group

1-drug Therapy

piperacillin-tazobactam

Group Type: EXPERIMENTAL

Piperacillin, Tazobactam Drug Combination

Intervention Type: DRUG

Single drug therapy

Interventions

Piperacillin, Tazobactam Drug Combination

Single drug therapy

Intervention Type: DRUG

Other Intervention Names

piperacillin-tazobactam; Zosyn

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Nonperforated Gangrenous Appendicitis
• Nonperforated Purulent Appendicitis
• Open Appendectomy

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Justin Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Childrens Hospital

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-011

Identifier Type: -

Identifier Source: org_study_id