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

Not Applicable

Terminated

• Conditions: Urinary Tract Infections
• Interventions: Device: McKesson Jelly; Device: BLASTX Gel

• Registration Number: NCT03176394
• Lead Sponsor: Next Science TM

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.

Study Timeline

• Study Start: 2017-05-24
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
McKesson Jelly Lubricated Catheter	McKesson Jelly	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.
BLASTX Lubricated Catheter	BLASTX Gel	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.

Primary Outcome Measures

Name	Time	Method
Urine microorganisms DNA analysis	Up to 14 days	Change in microorganisms in the test group compared to the control group.
Catheter microorganisms DNA analysis	Up to 14 days	Change in microorganisms in the test group compared to the control group.

Secondary Outcome Measures

Name	Time	Method
Incidence of Urinary Tract Infections (UTIs)	14 days	Number of instances of clinically symptomatic UTI in the test versus the control group

Trial Locations

Locations (1)

American Medical Research Institute; 🇺🇸 Celebration, Florida, United States