Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-11-30

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

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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.

Conditions

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Perforated Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

home intravenous ertapenem

Intervention Type DRUG

see arm description

peripheral inserted central Catheter

Intervention Type DEVICE

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

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).

Group Type EXPERIMENTAL

home oral amoxicillin-clavulanate

Intervention Type DRUG

see arm description

Interventions

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home intravenous ertapenem

see arm description

Intervention Type DRUG

home oral amoxicillin-clavulanate

see arm description

Intervention Type DRUG

peripheral inserted central Catheter

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

Intervention Type DEVICE

Other Intervention Names

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Invanz Augmentin PICC

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.

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No