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临床试验/EUCTR2020-004449-35-NL
EUCTR2020-004449-35-NL进行中(未招募)1 期

Antibiotic treatment following surgical drainage of perianal abscess: a double-blind, placebo-controlled, randomized trial

ZonMw0 个研究点目标入组 298 人开始时间: 2021年3月26日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
ZonMw
入组人数
298

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

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • -Men and women aged 18 years or older
  • -Eligible for e-mail questionnaires
  • -Sufficient understanding of the Dutch written language (reading and writing)
  • -Obtained written informed consent
  • 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 298
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -A coexistent perianal fistula
  • -Spontaneous drainage
  • -Secondary or recurrent perianal abscess
  • -Presence of an internal fistula opening
  • -Any additional surgical procedure performed during the same session
  • -Previous (peri)anal surgery
  • -Inflammatory bowel disease
  • -History of radiation of the pelvic area
  • -Anorectal malignancy
  • -Immunodeficiency
  • - Kidney failure, eGFR <30ml/min
  • -Valvular heart disease
  • -Pregnancy or lactation
  • -Antibiotic prophylaxis indicated for another reason
  • -Immunosuppressive medication at the time of surgery
  • -Allergy to metronidazole or ciprofloxacin
  • - Not able or trouble with swallowing pills
  • -Concomitant use of: tizadine, theopylline clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine, amiodarone, erytromcyine, sotalol, azithormycine, citalopram, escitalopram, flecainide, fluconazol, haloperidol >5mg/day, methadone, ondansetron, lithium, lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram, mebendazole, corticosteroids

研究者

发起方
ZonMw

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