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Antibiotic Duration in Post-appendectomy Abscess

Primary Purpose

Complicated Appendicitis, Perforated Appendicitis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ampicillin/clavulanate
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complicated Appendicitis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

8-day

4-day

Arm Description

8-day course of ampicillin clavulanate antibiotic

4--day course of ampicillin clavulanate antibiotic

Outcomes

Primary Outcome Measures

Hospital readmission rate
Number of times patient is readmitted to the hospital after their laparoscopy.
Length of hospital stay
How many days patient stays in the hospital if and when they are readmitted after their laparoscopy.
Rate of abdominal abscess
Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.

Secondary Outcome Measures

Rate of intra-abdominal wound infection
How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.

Full Information

First Posted
July 19, 2018
Last Updated
April 28, 2022
Sponsor
Phoenix Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03795194
Brief Title
Antibiotic Duration in Post-appendectomy Abscess
Official Title
A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to low enrollment.
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phoenix Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complicated Appendicitis, Perforated Appendicitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8-day
Arm Type
Other
Arm Description
8-day course of ampicillin clavulanate antibiotic
Arm Title
4-day
Arm Type
Other
Arm Description
4--day course of ampicillin clavulanate antibiotic
Intervention Type
Drug
Intervention Name(s)
ampicillin/clavulanate
Other Intervention Name(s)
Augmentin
Intervention Description
FDA-approved antibiotic
Primary Outcome Measure Information:
Title
Hospital readmission rate
Description
Number of times patient is readmitted to the hospital after their laparoscopy.
Time Frame
30 days
Title
Length of hospital stay
Description
How many days patient stays in the hospital if and when they are readmitted after their laparoscopy.
Time Frame
30 days
Title
Rate of abdominal abscess
Description
Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Rate of intra-abdominal wound infection
Description
How many times patient develops an intra-abdominal wound infection after discharge from the hospital after their laparoscopy.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Egan, MD
Organizational Affiliation
Phoenix Children's
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antibiotic Duration in Post-appendectomy Abscess

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