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Completed

NCT Number: NCT02724410

Role of Intravenous Versus Home Oral Antibiotics in Perforated Appendicitis

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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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

home intravenous ertapenem

Drug

see arm description

Other names: Invanz

home oral amoxicillin-clavulanate

Drug

see arm description

Other names: Augmentin

peripheral inserted central Catheter

Device

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

Other names: PICC

Primary outcomes

  1. Number of Participants With Postoperative Abscess

    Time frame: Thirty days after appendectomy

    Number of Postoperative Abscess, thirty-day postoperative

  2. Number of Participants With Wound Infections

    Time frame: Thirty days following appendectomy

    Number of Wound Infections, 30-days postoperative

  3. Number Participants With Readmission Within 30 Days

    Time frame: Thirty days following appendectomy

    Number of Readmission within 30 days postoperative

  4. Hospital Charge

    Time frame: Thirty days following appendectomy

    Cost of Hospital services

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 31, 2016
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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