Microbiological Characteristics of Biofilm on Double J Ureteral Stents After Lithotripsy: A Randomized Controlled Trial
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Antibiotic group
Patients of this group will receive Linezolid.
干预措施: Linezolid (LZD) (Drug)
Mucolytic group
Patients of this group will receive N-Acetylcysteine.
干预措施: N-Acetyl Cysteine (NAC) (Drug)
Combination group
Patients of this group will receive both Linezolid and N-Acetylcysteine.
干预措施: Linezolid (LZD) (Drug)
Combination group
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
Ammar Fathi Mohamed AlOrabi
Dr
Menoufia University
