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