Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Perforated Appendicitis

Intervention / Treatment
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* Drug: home intravenous ertapenem
* Drug: home oral amoxicillin-clavulanate
* Device: peripheral inserted central Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: home intravenous ertapenem and PICC<br>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<br>* see arm description<br>* Other names: Invanz;Device: peripheral inserted central Catheter<br>* All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.<br>* Other names: PICC;|
| Experimental: home oral amoxicillin-clavulanate<br>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<br>* see arm description<br>* Other names: Augmentin;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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appendectomy