A Trial for the Safety and Effectiveness of a Novel Antimicrobial-Coated Foley Catheter for Reduction of CAUTI.
Stopped early · Not applicable
Conditions studied: Urinary Tract Infection
In brief
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.
Key facts
- Study ID
- NCT01681511
- Run by
- Innovative Chemical and Environmental Technologies, Inc
- People needed
- 100
- Starts
- 2012-05-01
- Expected to finish
- 2013-01-01
- Last updated by the study team
- 2014-04-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Fairview medical center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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