Antibiotic Duration in Post-appendectomy Abscess

Perforated Appendicitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03795194
• Other study ID #: 17-055
• Status: Terminated
• Phase: Phase 4
• Start date: May 1, 2019
• Est. completion date: December 15, 2021

Study information

• Verified date: March 2024
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Appendicitis
• Complicated Appendicitis
• Perforated Appendicitis

Intervention

Drug:
• ampicillin/clavulanate
FDA-approved antibiotic

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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