Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

Perforated Appendicitis Clinical Trial

Official title:

Home Intravenous Versus Oral Antibiotics Following Appendectomy for Perforated Appendicitis in Children, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02724410
• Other study ID #: 08-10-13B
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: November 2013

Study information

• Verified date: February 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

Description:

Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

Inclusion Criteria:

• Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

Exclusion Criteria:

• Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.

Related Conditions & MeSH terms

• Appendicitis
• Perforated Appendicitis

Intervention

Drug:
• home intravenous ertapenem
see arm description
• home oral amoxicillin-clavulanate
see arm description

Device:
• peripheral inserted central Catheter
All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Postoperative Abscess	Number of Postoperative Abscess, thirty-day postoperative	Thirty days after appendectomy
Primary	Number of Participants With Wound Infections	Number of Wound Infections, 30-days postoperative	Thirty days following appendectomy
Primary	Number Participants With Readmission Within 30 Days	Number of Readmission within 30 days postoperative	Thirty days following appendectomy
Primary	Hospital Charge	Cost of Hospital services	Thirty days following appendectomy