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
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