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Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02198833
Recruitment Status : Terminated (Study catheter manufacturing issues. Poor enrollment.)
First Posted : July 24, 2014
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Rabih Darouiche, Baylor College of Medicine

Brief Summary:
The purpose of this study is to determine if the study Foley catheter with its patterned external surface can delay the time to the onset of urinary tract infection in spinal cord injury patients who are dependent on a Foley catheter for drainage of their urinary bladder.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Biological: Urine Culture Device: Foley Catheter Tip Culture Device: Scanning Electron Microscopy Procedure: Device Specific Adverse Event Assessment Procedure: Foley Catheter Insertion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Start Date : September 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


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
Biological: Urine Culture
Obtain urine culture every third day

Device: Foley Catheter Tip Culture
Catheter Tip Roll Plate Culture

Device: Scanning Electron Microscopy
Houston Site Only

Procedure: Device Specific Adverse Event Assessment
Assessment will be made of catheter patency and/or trauma related to catheter placement

Procedure: Foley Catheter Insertion
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
Biological: Urine Culture
Obtain urine culture every third day

Device: Foley Catheter Tip Culture
Catheter Tip Roll Plate Culture

Device: Scanning Electron Microscopy
Houston Site Only

Procedure: Device Specific Adverse Event Assessment
Assessment will be made of catheter patency and/or trauma related to catheter placement

Procedure: Foley Catheter Insertion
Insert Foley catheter for 15 day duration




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198833


Locations
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United States, Florida
James A. Haley Veterans' Hospital
Tampa, Florida, United States, 33612
United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
United States Department of Defense
Investigators
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Principal Investigator: Rabih O Darouiche, MD Baylor College of Medicine
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Responsible Party: Rabih Darouiche, Physician, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02198833    
Other Study ID Numbers: SC120028
H-32673 ( Other Identifier: Baylor College of Medicine )
First Posted: July 24, 2014    Key Record Dates
Results First Posted: April 7, 2017
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Number of patients entered in the study is too small for analysis of data.
Keywords provided by Rabih Darouiche, Baylor College of Medicine:
Urinary Tract Infection
Bacteriuria
Transurethral Foley Catheter
Suprapubic Foley Catheter
Spinal Cord injury
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Urologic Diseases