NL-OMON48812已完成不适用
The effect of rectal swab culture-guided antimicrobial prophylaxis in men undergoing prostate biopsy on infectious complications and cost of care: A randomized controlled trial in the Netherlands. - PRO-SWAP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,538
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Subject undergoes a transrectal prostate biopsy as part of the standard care
- •in one of the participating (study) centers (because of suspicion of prostate
- •- Subject is able and willing to sign the Informed Consent Form.
排除标准
- •- Inability to receive ciprofloxacin prophylaxis for any reason (e.g.
- •documented history of sensitivity to medicinal products or excipients similar
- •to those found in the antibiotic prophylaxis, relevant history or presence of
- •cardiovascular disorders (specific relevant QTc time prolongation), relevant
- •drug interaction).
- •- Inability to receive either co-trimoxazole, fosfomycin and
- •pivmecillinam/augmentin prophylaxis for any reason (e.g. documented history of
- •sensitivity to medicinal products or excipients similar to those found in the
- •antibiotic prophylaxis, relevant drug interaction).
- •- Inability to understand the nature of the trial and the procedures required.
- •- Individuals with an urinary tract infection or acute prostatitis within 14
- •days prior to transrectal prostate biopsy.
- •- Individuals who received antibiotics within 14 days prior to transrectal
- •prostate biopsy.
- •- Individuals who fail to send a rectum swab to the microbiology laboratory.
- •- Individuals whose rectal swab shows no growth on a Colombia blood agar (CBP)
- •(growth control)
研究者
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