'A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria.'
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters
研究概览
简要总结
A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter.
Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).
After the screening visit, the participants will be allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.
During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per guidelines
- •Patients aged 18+ years will be eligible for the study.
- •Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.
排除标准
- •Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.
- •Patients that have asymptomatic infection (if required may need a blood test to confirm)
- •Pregnant or Breastfeeding.
- •Patients with a potentially immunocompromised conditions (HIV)
- •Has a known silicone allergy or sensitivity
- •Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
- •Any medication deemed by the Investigator to potentially interfere with the study treatment
- •Participation in any other clinical study.
- •Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
结局指标
主要结局
The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters
时间窗: 1 Year
次要结局
- • Patient Reported Outcomes (PRO)(1 Year)
- • Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls(1 Year)
- • Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls(1 Year)
- • Reduction in Biofilm(1 Year)
- • Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls(1 Year)
- • Reduction in site infection(1 Year)