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临床试验/NCT07301294
NCT07301294尚未招募4 期

Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial

Menoufia University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
4 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Biofilm bacterial load

研究概览

简要总结

Indwelling Double J (DJ) ureteral stents are commonly used following lithotripsy to ensure adequate urinary drainage and prevent obstruction. However, stent-related biofilm formation remains a significant clinical problem, contributing to infection, encrustation, patient discomfort, and stent failure. Biofilms consist of microbial communities embedded within an extracellular polymeric substance (EPS), which protects microorganisms from host defenses and antimicrobial agents.

Antibiotic therapy alone may be insufficient to eradicate established biofilms due to poor penetration into the EPS matrix. Linezolid is a potent antibiotic with activity against gram-positive organisms commonly implicated in urinary tract colonization and penetrate and effectively act against bacterial biofilms. Mucolytic agents, by disrupting the biofilm matrix, may enhance antimicrobial penetration and reduce biofilm burden.

The combination of an antibiotic with a mucolytic agent may therefore provide superior biofilm reduction compared to either approach alone or no treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Antibiotic group

Active Comparator

Patients of this group will receive Linezolid.

干预措施: Linezolid (LZD) (Drug)

Mucolytic group

Active Comparator

Patients of this group will receive N-Acetylcysteine.

干预措施: N-Acetyl Cysteine (NAC) (Drug)

Combination group

Active Comparator

Patients of this group will receive both Linezolid and N-Acetylcysteine.

干预措施: Linezolid (LZD) (Drug)

Combination group

Active Comparator

Patients of this group will receive both Linezolid and N-Acetylcysteine.

干预措施: N-Acetyl Cysteine (NAC) (Drug)

结局指标

主要结局

Biofilm bacterial load

时间窗: 1 month

Biofilm bacterial load, defined as the quantity of bacteria within a biofilm, measured by culture of a swab taken off Double J stent after removal and expressed in numbers.

次要结局

  • Urinary tract infection rate(1 month)
  • Double J related symptoms(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ammar Fathi Mohamed AlOrabi

Dr

Menoufia University

研究点 (1)

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