Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

Not Applicable

Completed

• Conditions: Perforated Appendicitis
• Interventions: Drug: home oral amoxicillin-clavulanate; Drug: home intravenous ertapenem; Device: peripheral inserted central Catheter

• Registration Number: NCT02724410
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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

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 Timeline

• Study Start: 2011-01
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-25
• Study First Posted: 2016-03-31
• Status Verified: 2022-02
• Results First Submitted: 2022-02-28
• Results First Submitted QC: 2022-02-28
• Results First Posted: 2022-03-23
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
home intravenous ertapenem and PICC	peripheral inserted central Catheter	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)
home oral amoxicillin-clavulanate	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).
home intravenous ertapenem and PICC	home intravenous ertapenem	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)

Primary Outcome Measures

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