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

Next Science

Status: Terminated

Conditions: Urinary Tract Infections

Treatments: Device: McKesson Jelly; Device: BLASTX Gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03176394

CSP-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years or older
2. Absence of symptomatic UTI
3. Absence of upper/lower tract obstructions
4. No known allergies to the study products
5. Willing to comply with all study procedures and available for the duration of the study

Exclusion criteria

1. 17 years or younger
2. Symptomatic UTI
3. Presence of upper/lower tract obstructions
4. Known allergic reaction to the study products
5. Unable to provide signed and dated informed consent form

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

BLASTX Lubricated Catheter

Experimental group

Description:

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.

Treatment:

Device: BLASTX Gel

McKesson Jelly Lubricated Catheter

Placebo Comparator group

Description:

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.

Treatment:

Device: McKesson Jelly