Urinary Tract InfectionNCT02198833
Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection
A study testing Urine Culture, Foley Catheter Tip Culture and Scanning Electron Microscopy in people with Urinary Tract Infection, run by Baylor College of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Urine Culture, Foley Catheter Tip Culture and Scanning Electron Microscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
About this study
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
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.
Read the 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.
- Conditions
- Urinary Tract Infection
- Being tested
- Urine Culture, Foley Catheter Tip Culture, Scanning Electron Microscopy, Device Specific Adverse Event Assessment, Foley Catheter Insertion
- Keywords
- Urinary Tract Infection, Bacteriuria, Transurethral Foley Catheter, Suprapubic Foley Catheter, Spinal Cord injury
- Medical subject headings
- Urinary Tract Infections, Bacteriuria, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine CultureBiological
Obtain urine culture every third day
Foley Catheter Tip CultureDevice
Catheter Tip Roll Plate Culture
Scanning Electron MicroscopyDevice
Houston Site Only
Device Specific Adverse Event AssessmentProcedure or surgery
Assessment will be made of catheter patency and/or trauma related to catheter placement
Foley Catheter InsertionProcedure or surgery
Insert Foley catheter for 15 day duration
| Study group | Role | What they receive |
|---|---|---|
| Micro-Patterned Foley Catheter | Experimental | Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Receives: Biological: Urine Culture; Device: Foley Catheter Tip Culture; Device: Scanning Electron Microscopy; Procedure: Device Specific Adverse Event Assessment; Procedure: Foley Catheter Insertion |
| Standard-of-Care Foley Catheter | Active comparator | Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy Receives: Biological: Urine Culture; Device: Foley Catheter Tip Culture; Device: Scanning Electron Microscopy; Procedure: Device Specific Adverse Event Assessment; Procedure: Foley Catheter Insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 Days
Secondary outcomes (3)
Time to Occurrence of Asymptomatic Bacteruria or Funguria
Urine cultures will be obtained every third day to assess for the presence of microbial growth.
Measured: 15 days
Assess the Microbial Coverage and Biofilm Formation on Catheter Surface
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.
Measured: Day 15 or upon removal of Foley Catheter
Device Specific Adverse Event Assessments
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.
Measured: 15 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Study catheter manufacturing issues. Poor enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Rabih Darouiche, Baylor College of Medicine
- Investigators
- Rabih O Darouiche, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198833
- Sponsor's protocol ID
- SC120028
- Other IDs
- H-32673
- Status last verified
- Apr 2017
- First submitted
- 21 Jul 2014
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Number of patients entered in the study is too small for analysis of data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02198833
- Acronym / sponsor ID
- SC120028
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary Tract Infection, Bacteriuria, Transurethral Foley Catheter, Suprapubic Foley Catheter, Spinal Cord injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study catheter manufacturing issues. Poor enrollment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Jul 2014 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro-Patterned Foley Catheter | Experimental | Biological: Urine Culture, Device: Foley Catheter Tip Culture, Device: Scanning Electron Microscopy, Procedure: Device Specific Adverse Event Assessment, Procedure: Foley Catheter InsertionProcedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy |
| Standard-of-Care Foley Catheter | Active comparator | Biological: Urine Culture, Device: Foley Catheter Tip Culture, Device: Scanning Electron Microscopy, Procedure: Device Specific Adverse Event Assessment, Procedure: Foley Catheter InsertionProcedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine CultureObtain urine culture every third day | Biological | Micro-Patterned Foley Catheter, Standard-of-Care Foley Catheter |
| Foley Catheter Tip CultureCatheter Tip Roll Plate Culture | Device | Micro-Patterned Foley Catheter, Standard-of-Care Foley Catheter |
| Scanning Electron MicroscopyHouston Site Only | Device | Micro-Patterned Foley Catheter, Standard-of-Care Foley Catheter |
| Device Specific Adverse Event AssessmentAssessment will be made of catheter patency and/or trauma related to catheter placement | Procedure or surgery | Micro-Patterned Foley Catheter, Standard-of-Care Foley Catheter |
| Foley Catheter InsertionInsert Foley catheter for 15 day duration | Procedure or surgery | Micro-Patterned Foley Catheter, Standard-of-Care Foley Catheter |
Primary outcome
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.
3 secondary outcomes
Time to Occurrence of Asymptomatic Bacteruria or Funguria
Time frame: 15 days
Assess the Microbial Coverage and Biofilm Formation on Catheter Surface
Time frame: Day 15 or upon removal of Foley Catheter
Device Specific Adverse Event Assessments
Time frame: 15 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Number of patients entered in the study is too small for analysis of data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabih O Darouiche, MD principal investigator
Baylor College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine Culture, Foley Catheter Tip Culture and Scanning Electron Microscopy in people with Urinary Tract Infection, run by Baylor College of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delay Onset of Catheter Associated Symptomatic Urinary Tract Infection (time frame: 15 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2017.