Study Stopped
Study catheter manufacturing issues. Poor enrollment.
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
2 other identifiers
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedResults Posted
Study results publicly available
April 7, 2017
CompletedApril 7, 2017
April 1, 2017
10 months
July 21, 2014
February 1, 2017
April 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection
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 Outcomes (3)
Time to Occurrence of Asymptomatic Bacteruria or Funguria
15 days
Assess the Microbial Coverage and Biofilm Formation on Catheter Surface
Day 15 or upon removal of Foley Catheter
Device Specific Adverse Event Assessments
15 Days
Study Arms (2)
Micro-Patterned Foley Catheter
EXPERIMENTALProcedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Standard-of-Care Foley Catheter
ACTIVE COMPARATORProcedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baylor College of Medicinelead
- United States Department of Defensecollaborator
Study Sites (2)
James A. Haley Veterans' Hospital
Tampa, Florida, 33612, United States
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Two major factors: 1) Production of the study catheter took much longer than expected. Only size 16 French Foley available; and 2) The inability to clear asymptomatic bacteriuria from patients' urinary bladder prior to study catheter placement.
Results Point of Contact
- Title
- Rabih Darouiche, MD
- Organization
- Baylor College of Medcine
Study Officials
- PRINCIPAL INVESTIGATOR
Rabih O Darouiche, MD
Baylor College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
July 21, 2014
First Posted
July 24, 2014
Study Start
September 1, 2014
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
April 7, 2017
Results First Posted
April 7, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share
Number of patients entered in the study is too small for analysis of data.