- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198833
Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection
Clinical Study to Assess the Efficacy of a Novel Micro-Patterned Foley Catheter to Reduce Catheter-Associated UrinaryTract Infection Among Spinal Cord Injury Patients
Study Overview
Status
Conditions
Detailed Description
Roughly half of the two million nosocomial infections that occur each year are associated with the use of a medical device. Approximately 30 million urinary catheters are inserted each year into the bladder of over five million patients, and each catheterized patient is at risk of developing catheter-associated symptomatic urinary tract infection. About 95% of urinary tract infections are associated with the use of a urinary catheter. Not only is catheter associated urinary tract infection the most common nosocomial infection in general, but it is also the most common infectious reason for admission to the hospital among the population of 275 thousand Americans with spinal cord injury, which expands by approximately 12 thousand persons each year. Hospital-acquired infections boost today's healthcare costs by billions of dollars and healthcare providers are increasingly responsible for shouldering these costs.
Catheter-associated symptomatic urinary tract infection is usually caused by organisms that originate from the patient's own colonic and perineal flora, or the hands of healthcare personnel during catheter insertion and manipulation of the collection system. Microbial species predominantly migrate into the bladder extraluminally via the mucoid film that forms between the catheter surface and the urethra. Current approaches for preventing catheter-related infections include antimicrobial modification of the catheter surface. Although these antimicrobial-based catheters aim to eradicate bacteria residing in the vicinity of the catheter surface, they can result in antibiotic resistance, which could have serious implications on patient care.
A novel urinary catheter, the Micro-Patterned Foley catheter has been developed that incorporates a micro-pattern texture on the surface; the texture is too small to see or feel, but has demonstrated an impressive effect in the laboratory inhibiting microbial attachment to the surface and microbial migration along the micro-patterned catheter segments. The objective of the study is to determine whether the novel Micro-Patterned catheter can delay the onset of catheter associated urinary tract infection in catheterized spinal cord injured patients. If successful, this catheter will help improve quality of patient care and reduce cost of care by reducing the need for antibiotic treatment. This finding could extend to other patient populations that require urinary catheterization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- James A. Haley Veterans' Hospital
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey Veterans Affairs Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Veteran
- Hospitalized in one of the two participating Spinal Cord Injury Units
- Require a size 14, 16, or 18 French catheter
- Sign and date the written informed consent document acknowledging his/her desire to participate in the study, or if unable to sign due to spinal cord injury give verbal consent in front of two impartial witnesses who sign and date the informed consent document in the presence of the participant
- Be able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
- Require insertion or exchange of a Foley catheter for no longer than 15 days.
Exclusion Criteria
- Unable to provide informed consent
- Has a current symptomatic urinary tract infection
- Has persistent bacteriuria that cannot be cleared with antimicrobial agents to a nominal level of less than 1,000 Colony Forming Units/mL prior to study catheter insertion
- Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy
- Has periurethral inflammation or infection
- Has a known urethral anatomical anomaly which makes catheterization difficult
- Has a known silicone allergy or sensitivity
- Cannot accommodate a size 14,16 or 18 French Foley catheter.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Micro-Patterned Foley Catheter
Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
|
Obtain urine culture every third day
Catheter Tip Roll Plate Culture
Houston Site Only
Assessment will be made of catheter patency and/or trauma related to catheter placement
Insert Foley catheter for 15 day duration
|
Active Comparator: Standard-of-Care Foley Catheter
Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
|
Obtain urine culture every third day
Catheter Tip Roll Plate Culture
Houston Site Only
Assessment will be made of catheter patency and/or trauma related to catheter placement
Insert Foley catheter for 15 day duration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection
Time Frame: 15 Days
|
Patients will be assessed daily for the occurrence of signs and symptoms of urinary tract infection.
A single, independent evaluator (PI/co-investigator) will determine whether the subject has a catheter associated urinary tract infection based on pre-defined criteria that involve symptom reports and lab values without knowledge of or access to the catheter type randomly assigned to the patient.
|
15 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Occurrence of Asymptomatic Bacteruria or Funguria
Time Frame: 15 days
|
Urine cultures will be obtained every third day to assess for the presence of microbial growth.
|
15 days
|
Assess the Microbial Coverage and Biofilm Formation on Catheter Surface
Time Frame: Day 15 or upon removal of Foley Catheter
|
Catheters will be cultured by Roll-plate method for microbial growth.
Catheters removed at the Houston site will also be evaluated by scanning electron microscopy to determine microbial coverage and biofilm formation.
|
Day 15 or upon removal of Foley Catheter
|
Device Specific Adverse Event Assessments
Time Frame: 15 Days
|
Patient will be assessed daily for signs and symptoms of infection.
Catheter placement and patency will be confirmed.
Insertion site will be evaluated for signs of inflammation and or trauma.
|
15 Days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rabih O Darouiche, MD, Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SC120028
- H-32673 (Other Identifier: Baylor College of Medicine)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Tract Infection
-
Gloucestershire Hospitals NHS Foundation TrustUnknownCatheter Infection | Urinary Tract Infection in Pregnancy | Urinary Tract Infection Following Delivery
-
Lawson Health Research InstituteUniversity of Western Ontario, CanadaCompletedUrinary Tract Infection | Recurrent Urinary Tract InfectionCanada
-
Hadassah Medical OrganizationUnknown
-
National Center for Complementary and Integrative...Office of Dietary Supplements (ODS)UnknownUrinary Tract InfectionCanada
-
National Institute of Allergy and Infectious Diseases...TerminatedUrinary Tract InfectionUnited States
-
University Of PerugiaUnknownUrinary Tract Infection
-
NanovibronixShaare Zedek Medical CenterUnknownUrinary Tract InfectionIsrael
-
Impatients N.V. trading as myTomorrowsInmunotek S.L.No longer availableUrinary Tract Infections | Bladder Infection | Recurrent Urinary Tract Infection | Urinary Tract Infection Bacterial | Chronic Urinary Tract InfectionCzechia, Denmark, Serbia, France, Germany, Turkey, Belgium, Finland, Luxembourg, Netherlands, Norway, Romania, Slovakia, Slovenia, Sweden
-
Bactiguard ABRehab Station StockholmCompletedComplications; Catheter, Urinary Infection or InflammationSweden
-
University of ManitobaTerminatedComplicated Urinary InfectionCanada
Clinical Trials on Urine Culture
-
Shaare Zedek Medical CenterCompletedUrinary Tract Infection
-
Assiut UniversityEnrolling by invitation
-
Assiut UniversityNot yet recruiting
-
Swiss Paraplegic Centre NottwilCompletedUrinary Tract InfectionSwitzerland
-
Ain Shams UniversityUnknownUrinary Tract Infection
-
Batool MutarCompleted
-
Loyola UniversityCompletedUrinary Tract InfectionsUnited States
-
Hadassah Medical OrganizationUnknown
-
Trabzon Arakli Bayram Halil Public HospitalRecruitingType2diabetes, SGLT2 Inhibitor, Urinary Tract InfectionTurkey
-
The Cleveland ClinicTerminatedOveractive Bladder | Overactive Detrusor | UTI | Urgency-Frequency SyndromeUnited States