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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03176394
• Other study ID #: CSP-005
• Status: Terminated
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: October 18, 2019

Study information

• Verified date: November 2023
• Source: Next Science TM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteriuria
• Urinary Tract Infections

Intervention

Device:
• BLASTX Gel
Foley Catheter lubricated with BLASTX Gel
• McKesson Jelly
Foley Catheter lubricated with McKesson Jelly

Locations

Country	Name	City	State
United States	American Medical Research Institute	Celebration	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Next Science TM

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine microorganisms DNA analysis	Change in microorganisms in the test group compared to the control group.	Up to 14 days
Primary	Catheter microorganisms DNA analysis	Change in microorganisms in the test group compared to the control group.	Up to 14 days
Secondary	Incidence of Urinary Tract Infections (UTIs)	Number of instances of clinically symptomatic UTI in the test versus the control group	14 days