Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

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

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

Study Overview

• Status: Completed
• Conditions: Perforated Appendicitis
• Intervention / Treatment: Drug: home intravenous ertapenem; Device: peripheral inserted central Catheter; Drug: home oral amoxicillin-clavulanate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: home intravenous ertapenem and PICC; Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)	Drug: home intravenous ertapenem; see arm description; Other Names: Invanz; 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.; Other Names: PICC
EXPERIMENTAL: home oral amoxicillin-clavulanate; Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).	Drug: home oral amoxicillin-clavulanate; see arm description; Other Names: Augmentin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Brant T Heniford, M.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: March 25, 2016
• First Posted (ESTIMATE): March 31, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: appendectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Cecal Diseases; Intraabdominal Infections; Appendicitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Ertapenem; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 08-10-13B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED