A Randomized Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter Attached to an Antimicrobial Anti-Reflux Device for Reduction of Catheter-Associated Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The Proportion of Subjects With at Least One CAUTI
研究概览
简要总结
The primary objective of this pilot study is to demonstrate the feasibility of recruiting eligible patients for the purposes of assessing the temporal aspects and rates of Catheter Associated Urinary Tract Infection (CAUTI), based on the agreed-upon case definition so that the numbers needed for a pivotal study can be better estimated.
详细描述
This pilot study will be a prospective, single site, randomized clinical investigation comparing the safety and effectiveness of the ICET TIC antimicrobial Foley catheter, against the infection control standard-of-care, the BARD ® LUBRI-SIL® I.C. Foley catheter.
Approximately 160 patients will be screened. The study has been designed to enroll approximately 120 eligible subjects to obtain about 60 evaluable subjects (30 in each arm). Subjects who meet the eligibility criteria will be enrolled into the study and randomly assigned to the experimental or standard-of-care group in a 1:1 ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Subject is at least 18 years of age
- •Subject is expected to be catheterized with 14 or 16 French Foley catheters for at least 72 hours.
- •Subject (or a legally authorized representative) has provided written informed consent for study participation and procedures to be performed.
- •Life expectancy at least 3 months or more in the judgment of the investigator
排除标准
- •Subjects who present with previously known, symptomatic UTI
- •Subjects with a positive urine dipstick at the time of enrollment
- •Subjects who are on systemic antibiotics within 48 hours prior to enrollment
- •Subjects with a known of suspected allergy to silicone, silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis.
- •Subjects who have had an indwelling catheter removed less than 48 hours before study enrollment.
- •Current genitourinary tract surgery or known infection
- •Subject requires use of a non-study urinary catheter
- •Subjects known to be pregnant or breast feeding at the time of enrollment
结局指标
主要结局
The Proportion of Subjects With at Least One CAUTI
时间窗: 48 ± 24 hours or more
CAUTI is as determined by blinded investigator assessment per protocol definition. DAYS TO CAUTI = (DATE OF EVENT - DATE OF CZD INSERTION) + 1. Date of event for subjects who had CAUTI is the date of urine sample collection where the CAUTI criteria are met. Date of event for subjects who did not have CAUTI is the last available urine culture collection date from samples collected during \& post CZD. p-values of time of CAUTI were obtained from log-rank test. p-values of Incidence of CAUTI were obtained from the Logistic Regression Model. Evaluable population (EP) refers to all randomized subjects successfully CZD \& stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting \>24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP. CZD = Catheterized or catheter
Number of Subjects Affected, During Treatment and Follow-up Time Periods, by a Catheter Associated Urinary Tract Infection (CAUTI) Event After First CAUTI Event.
时间窗: up to 30th day from the time of catheterization
All randomized subjects will be followed until (1) up to 30th day from the time of catheterization or (2) the subject withdraws or is discharged from the hospital, whichever comes first and (3) 48 hours after the catheter is removed. Evaluable population (EP) refers to all randomized subjects successfully CZD \& stayed on the CZD for ≥ 48 ± 24 hours or more without any systemic (postoperative) antibiotic for CZD/non-CZD related reasons. Subjects receiving an intercurrent course of systemic antibiotics lasting \>24 hours other than surgical prophylaxis were considered non-evaluable in all analyses of effectiveness endpoints using the EP.
次要结局
- The Proportion of Subjects With Symptomatic Urinary Tract Infection (SUTI)(up to 30th day from the time of catheterization)
- The Proportion of Subjects With Asymptomatic Bacteremic Urinary Tract Infection (ABUTI)(up to 30th day from the time of catheterization)