Antibiotic Duration in Post-appendectomy Abscess

A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess

This is a randomized study of patients 2-17 years old who are diagnosed with perforated appendicitis and develop an abscess after laparoscopy that is subsequently drained. Patients will be randomized to either receive an 8-day or a 4-day course of antibiotics. The aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in clinical outcomes.

Study Overview

• Status: Terminated
• Conditions: Complicated Appendicitis; Perforated Appendicitis
• Intervention / Treatment: Drug: ampicillin/clavulanate

Detailed Description

The central aim of this study is to determine whether duration of antibiotic treatment at discharge demonstrates significant differences in primary and secondary clinical outcomes. Specifically, this research aims to determine whether the readmission rate and length of stay for pediatric patients diagnosed with perforated appendicitis who form a post-laparoscopic abscess that is treated with percutaneous drainage and are treated with a 8-day oral antibiotic regimen at discharge is significantly different from those treated with a fixed 4-day regimen at discharge.

This study includes patients ages 2-17 years old who present with perforated appendicitis-as diagnosed at laparoscopy and photographed as either a hole or as feces in the abdomen-and who develop an abscess after laparoscopy that is treated with percutaneous drainage.

All post-laparoscopic abscess patients will receive the standard of care for antibiotic therapy at Phoenix Children's Hospital-IV ceftriaxone/metronidazole-until afebrile and tolerating food. All patients will be treated with the PCH standard of care and receive in-patient treatment for abscess until afebrile.

At discharge, study patients will be randomly assigned to either an 8-day ampicillin/clavulanate regimen or a 4-day ampicillin/clavulanate regimen. Pediatric patients who are allergic to ampicillin will be excluded from the study. Patients will be followed thirty days post discharge to assess clinical outcomes.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 2 to 17 years of age
• Diagnosis of perforated appendicitis at laparoscopy
• Development of a post-appendectomy abscess that is treated with percutaneous drainage.

Exclusion Criteria:

• Patients who are allergic to ampicillin

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 8-day; 8-day course of ampicillin clavulanate antibiotic	Drug: ampicillin/clavulanate; FDA-approved antibiotic; Other Names: Augmentin
Other: 4-day; 4--day course of ampicillin clavulanate antibiotic	Drug: ampicillin/clavulanate; FDA-approved antibiotic; Other Names: Augmentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Readmission Rate	Rate of readmission to the hospital after abscess drainage.	30 days
Length of Hospital Stay	How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intra-abdominal wound infection	How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.	30 days

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital
• Investigators: Principal Investigator: Craig Egan, MD, Phoenix Children's

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: January 3, 2019
• First Posted (Actual): January 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• 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; Ampicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: 17-055 (Truman Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No