Skip to main content
Clinical Trials/NCT03795194
NCT03795194
Terminated
Phase 4

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

Phoenix Children's Hospital1 site in 1 country7 target enrollmentMay 1, 2019

Overview

Phase
Phase 4
Intervention
ampicillin/clavulanate
Conditions
Complicated Appendicitis
Sponsor
Phoenix Children's Hospital
Enrollment
7
Locations
1
Primary Endpoint
Hospital Readmission Rate
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2019
End Date
December 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

8-day

8-day course of ampicillin clavulanate antibiotic

Intervention: ampicillin/clavulanate

4-day

4--day course of ampicillin clavulanate antibiotic

Intervention: ampicillin/clavulanate

Outcomes

Primary Outcomes

Hospital Readmission Rate

Time Frame: 30 days

Rate of readmission to the hospital after abscess drainage.

Length of Hospital Stay

Time Frame: 30 days

How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.

Study Sites (1)

Loading locations...

Similar Trials