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临床试验/EUCTR2019-001002-18-ES
EUCTR2019-001002-18-ES进行中(未招募)1 期

Pathophysiological mechanisms in the development of anal fistula. Oral antibiotics after anal abscess drainage to diminish perianal Fistula Formation: a multicenter, randomized, observer-blind, placebo-controlled clinical trial. - O.F.F.

Hospital Universitari Germans Trias i Pujol0 个研究点目标入组 210 人开始时间: 2021年2月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
210

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 18 years or more
  • Both genders
  • Clinical diagnosis of anal abscess (acute inflammatory signs and presence of a purulent collection in the perianal area) seen or confirmed through punction aspiration of purulent material with needle.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 150
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • Inflammatory bowel disease
  • Anal surgical history
  • Anal fistula alredy konwn
  • Anal carcinoma and/or pelvic radiotherapy
  • Anal trauma history
  • horse shoe abscess
  • Inmunodeficiency, diabetes, pregnancy or lactation, heart valve disease or prosthetic valve carriers
  • Spontaneous drainage of abscess
  • Antibiotics use
  • Contraindications of ciprofloxacin according to SPC (hypersensitivity to the active principle, or to other quinolones or to any of the excipients; concomitant administration of ciprofloxacin and tizanidine)
  • - Contraindications of metronidazole according to SPC (hypersensitivity to imidazoles or to any of the excipients)
  • -Pregnancy and lactation

研究者

发起方
Hospital Universitari Germans Trias i Pujol

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