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
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
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