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临床试验/NCT02724410
NCT02724410已完成不适用

Home Intravenous Versus Oral Antibiotics Following Appendectomy for Perforated Appendicitis in Children, a Randomized Controlled Trial

Wake Forest University Health Sciences0 个研究点目标入组 82 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
主要终点
Number of Participants With Postoperative Abscess

研究概览

简要总结

To compare the effect of a single-agent home intravenous (IV) versus oral antibiotic therapy on complication rates and resource utilization following appendectomy for perforated appendicitis

详细描述

Appendicitis is the most common cause of abdominal pain requiring emergent surgical intervention in children and approximately one third of patients present with perforation. Perforated appendicitis has been demonstrated to have a significant impact on patients and families due to the prolonged hospitalization, high complication rates, and tremendous economic burden from treatment. The most significant complication following operative treatment of perforated appendicitis is intra-abdominal abscess, which develops in approximately 20% of children following appendectomy in recent literature. Due to this frequent and morbid complication, continued research has been driven at determining the most efficacious and cost-effective postoperative antibiotic treatment regimen to reduce post-operative abscess. As postoperative abscess rates following appendectomy for perforated appendicitis remain high, the primary aim of this study was to evaluate a new postoperative antibiotic treatment regimen based on single daily dosing ertapenem while inpatient with randomization into ten day completion course of home antibiotics with IV ertapenem versus oral amoxicillin/clavulanate. The hypothesis is that the ertapenem based regimen will offer reduced rates of postoperative abscess, with no major difference between completion courses of home IV versus oral antibiotics.

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
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients 4-17 years of age with perforated acute appendicitis diagnosed at time of appendectomy.

排除标准

  • Patients with a known severe allergy to penicillin (anaphylaxis), prior severe side effects from ertapenem or amoxicillin-clavulanate, pregnancy, or previous drainage procedure for abscess and/or fluid collection related to appendicitis.

研究组 & 干预措施

home intravenous ertapenem and PICC

Active Comparator

Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)

干预措施: home intravenous ertapenem (Drug)

home intravenous ertapenem and PICC

Active Comparator

Placement of peripheral inserted central catheter (PICC) and completion of ten day antibiotic treatment with home (IV) ertapenem (Drug Class:carbapenem antibiotic) (15 mg/kg IV every twelve hours not to exceed 1 gm/day for ages <13; age 13 or greater, then 1 gm daily)

干预措施: peripheral inserted central Catheter (Device)

home oral amoxicillin-clavulanate

Experimental

Completion of ten day antibiotic treatment with home oral amoxicillin-clavulanate(Drug Class:beta lactam antibiotic)(15mg/kg every eight hours or 22.5mg/kg extended release tablets every twelve hours).

干预措施: home oral amoxicillin-clavulanate (Drug)

结局指标

主要结局

Number of Participants With Postoperative Abscess

时间窗: Thirty days after appendectomy

Number of Postoperative Abscess, thirty-day postoperative

Number of Participants With Wound Infections

时间窗: Thirty days following appendectomy

Number of Wound Infections, 30-days postoperative

Number Participants With Readmission Within 30 Days

时间窗: Thirty days following appendectomy

Number of Readmission within 30 days postoperative

Hospital Charge

时间窗: Thirty days following appendectomy

Cost of Hospital services

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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