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

NCT ID: NCT03176394

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-24
• Study Completion Date: 2019-10-18

Brief Summary

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

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.

Conditions

Urinary Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

BLASTX Lubricated Catheter

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.

Group Type: EXPERIMENTAL

BLASTX Gel

Intervention Type: DEVICE

Foley Catheter lubricated with BLASTX Gel

McKesson Jelly Lubricated Catheter

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.

Group Type: PLACEBO_COMPARATOR

McKesson Jelly

Intervention Type: DEVICE

Foley Catheter lubricated with McKesson Jelly

Interventions

BLASTX Gel

Foley Catheter lubricated with BLASTX Gel

Intervention Type: DEVICE

McKesson Jelly

Foley Catheter lubricated with McKesson Jelly

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Next Science TM

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Greco, MD

Role: STUDY_DIRECTOR

Next Science

Locations

American Medical Research Institute

Celebration, Florida, United States

Countries

United States

Other Identifiers

CSP-005

Identifier Type: -

Identifier Source: org_study_id