Antibiotic Duration in Post-appendectomy Abscess

NCT ID: NCT03795194

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-12-15

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.

Conditions

Complicated Appendicitis; Perforated Appendicitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

8-day

8-day course of ampicillin clavulanate antibiotic

Group Type: OTHER

ampicillin/clavulanate

Intervention Type: DRUG

FDA-approved antibiotic

4-day

4--day course of ampicillin clavulanate antibiotic

Group Type: OTHER

ampicillin/clavulanate

Intervention Type: DRUG

FDA-approved antibiotic

Interventions

ampicillin/clavulanate

FDA-approved antibiotic

Intervention Type: DRUG

Other Intervention Names

Augmentin

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Phoenix Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Egan, MD

Role: PRINCIPAL_INVESTIGATOR

Phoenix Children's

Locations

Phoenix Children's Hospital

Phoenix, Arizona, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-055

Identifier Type: -

Identifier Source: org_study_id