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临床试验/NCT03289351
NCT03289351已完成4 期

Randomized Control Trial: Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis

Phoenix Children's Hospital2 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2017年5月22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
已完成
入组人数
162
试验地点
2
主要终点
Number of Participants With a Postoperative Intra-abdominal Abscess

研究概览

简要总结

After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.

详细描述

The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Postoperative Perforated Appendicitis (documented by intraoperative photo)
  • Postoperative Laparoscopic Appendectomy

排除标准

  • Nonperforated Gangrenous Appendicitis
  • Nonperforated Purulent Appendicitis
  • Open Appendectomy

研究组 & 干预措施

1-drug Therapy

Experimental

piperacillin-tazobactam

干预措施: Piperacillin, Tazobactam Drug Combination (Drug)

结局指标

主要结局

Number of Participants With a Postoperative Intra-abdominal Abscess

时间窗: 30 days

Intra-abdominal abscess documented by ultrasound or computerized tomography

次要结局

  • Number of Participants With Postoperative Surgical Site Infection(30 days)
  • Number of Participants With a Postoperative Readmission(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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