Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Postoperative Infection Clinical Trial

Official title:

Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289351
• Other study ID #: 17-011
• Status: Completed
• Phase: Phase 4
• Start date: May 22, 2017
• Est. completion date: November 7, 2023

Study information

• Verified date: March 2023
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: November 7, 2023
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Postoperative Perforated Appendicitis (documented by intraoperative photo)

• Postoperative Laparoscopic Appendectomy

Exclusion Criteria:

• Nonperforated Gangrenous Appendicitis

• Nonperforated Purulent Appendicitis

• Open Appendectomy

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis
• Postoperative Infection

Intervention

Drug:
• Piperacillin, Tazobactam Drug Combination
Single drug therapy

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Postoperative Intra-abdominal Abscess	Intra-abdominal abscess documented by ultrasound or computerized tomography	30 days
Secondary	Number of Participants With Postoperative Surgical Site Infection	surgical site infections including superficial port site infection	30 days
Secondary	Number of Participants With a Postoperative Readmission	readmission within 30 days for any gastrointestinal complaints or infectious complications	30 days