Antibiotic Duration in Post-appendectomy Abscess

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complicated Appendicitis, Perforated Appendicitis

Intervention / Treatment
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* Drug: ampicillin/clavulanate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 8-day<br>8-day course of ampicillin clavulanate antibiotic | Drug: ampicillin/clavulanate<br>* FDA-approved antibiotic<br>* Other names: Augmentin;|
| Other: 4-day<br>4--day course of ampicillin clavulanate antibiotic | Drug: ampicillin/clavulanate<br>* FDA-approved antibiotic<br>* Other names: Augmentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital readmission rate | Number of times patient is readmitted to the hospital after their laparoscopy. | 30 days | 
| Length of hospital stay | How many days patient stays in the hospital if and when they are readmitted after their laparoscopy. | 30 days | 
| Rate of abdominal abscess | Number of times patient develops abdominal abscess after discharge from hospital after their laparoscopy. | 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 |