Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)

Study Overview
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Brief Summary
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This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.

Detailed Description
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This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term < 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters. Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration. Informed consent discussion will be completed, ICF will be signed, prior to any study procedures. Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met. After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.

Official Title
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Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Device: BLASTX Gel
* Device: McKesson Jelly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Absence of symptomatic UTI Absence of upper/lower tract obstructions No known allergies to the study products Willing to comply with all study procedures and available for the duration of the study Exclusion Criteria: 17 years or younger Symptomatic UTI Presence of upper/lower tract obstructions Known allergic reaction to the study products Unable to provide signed and dated informed consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLASTX Lubricated Catheter<br>Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with BLASTX. This gel lubricates with the same viscosity as McKesson Jelly and has a biofilm disruptive active ingredient. | Device: BLASTX Gel<br>* Foley Catheter lubricated with BLASTX Gel<br>|
| Placebo Comparator: McKesson Jelly Lubricated Catheter<br>Subjects for which catheterization is prescribed will be catheterized with a Foley lubricated with McKesson Jelly. This jelly lubricates with the same viscosity as BLASTX but has no biofilm disruptive active ingredient. | Device: McKesson Jelly<br>* Foley Catheter lubricated with McKesson Jelly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine microorganisms DNA analysis | Change in microorganisms in the test group compared to the control group. | Up to 14 days | 
| Catheter microorganisms DNA analysis | Change in microorganisms in the test group compared to the control group. | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Urinary Tract Infections (UTIs) | Number of instances of clinically symptomatic UTI in the test versus the control group | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Foley, UTI, Biofilm, DNA