Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

NCT03289351 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-011
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Perforated Appendicitis; Postoperative Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Postoperative Intra-abdominal Abscess

  Intra-abdominal abscess documented by ultrasound or computerized tomography

  30 days

Secondary Outcomes (2)

• Number of Participants With Postoperative Surgical Site Infection

  30 days

• Number of Participants With a Postoperative Readmission

  30 days

Study Arms (2)

2-drug Therapy

NO INTERVENTION

ceftriaxone/metronidazole

1-drug Therapy

EXPERIMENTAL

piperacillin-tazobactam

Drug: Piperacillin, Tazobactam Drug Combination

Interventions

Piperacillin, Tazobactam Drug Combination DRUG

Single drug therapy

Also known as: piperacillin-tazobactam, Zosyn

1-drug Therapy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Nonperforated Gangrenous Appendicitis
• Nonperforated Purulent Appendicitis
• Open Appendectomy

Sponsors & Collaborators

• Phoenix Children's Hospital: lead

Study Sites (2)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Tazobactam; Penicillanic Acid; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Piperacillin; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Justin Lee
• Organization: Phoenix Children's

jlee8@phoenixchildrens.com

6029330016

Study Officials

• Justin Lee, MD

  Phoenix Childrens Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: May 22, 2017
• Primary Completion: November 17, 2021
• Study Completion: November 7, 2023
• Last Updated: January 12, 2024
• Results First Posted: January 12, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)