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临床试验/NCT03795194
NCT03795194终止4 期

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

Phoenix Children's Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
7
试验地点
1
主要终点
Hospital Readmission Rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patients who are allergic to ampicillin

研究组 & 干预措施

8-day

Other

8-day course of ampicillin clavulanate antibiotic

干预措施: ampicillin/clavulanate (Drug)

4-day

Other

4--day course of ampicillin clavulanate antibiotic

干预措施: ampicillin/clavulanate (Drug)

结局指标

主要结局

Hospital Readmission Rate

时间窗: 30 days

Rate of readmission to the hospital after abscess drainage.

Length of Hospital Stay

时间窗: 30 days

How many days patient stays in the hospital if and when they are readmitted after their abscess drainage.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Antibiotic Duration in Post-appendectomy Abscess | 临床试验