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

Primary Purpose

Urinary Tract Infections

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BLASTX Gel

McKesson Jelly

About this trial

This is an interventional basic science trial for Urinary Tract Infections focused on measuring Foley, UTI, Biofilm, DNA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

American Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BLASTX Lubricated Catheter

McKesson Jelly Lubricated Catheter

Arm 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.

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.

Outcomes

Primary Outcome Measures

Urine microorganisms DNA analysis

Change in microorganisms in the test group compared to the control group.

Catheter microorganisms DNA analysis

Change in microorganisms in the test group compared to the control group.

Secondary Outcome Measures

Incidence of Urinary Tract Infections (UTIs)

Number of instances of clinically symptomatic UTI in the test versus the control group

Full Information

NCT ID

NCT03176394

First Posted

May 30, 2017

Last Updated

April 17, 2023

Sponsor

Next Science TM

1. Study Identification

Unique Protocol Identification Number

NCT03176394

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Terminated

Why Stopped

trouble with enrollment

Study Start Date

May 24, 2017 (Actual)

Primary Completion Date

October 18, 2019 (Actual)

Study Completion Date

October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Next Science TM

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

Foley, UTI, Biofilm, DNA

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BLASTX Lubricated Catheter

Arm Type

Experimental

Arm Description

Arm Title

McKesson Jelly Lubricated Catheter

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

BLASTX Gel

Intervention Description

Foley Catheter lubricated with BLASTX Gel

Intervention Type

Device

Intervention Name(s)

McKesson Jelly

Intervention Description

Foley Catheter lubricated with McKesson Jelly

Primary Outcome Measure Information:

Title

Urine microorganisms DNA analysis

Description

Change in microorganisms in the test group compared to the control group.

Time Frame

Up to 14 days

Title

Catheter microorganisms DNA analysis

Description

Change in microorganisms in the test group compared to the control group.

Time Frame

Up to 14 days

Secondary Outcome Measure Information:

Title

Incidence of Urinary Tract Infections (UTIs)

Description

Number of instances of clinically symptomatic UTI in the test versus the control group

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan Greco, MD

Organizational Affiliation

Next Science

Official's Role

Study Director

Facility Information:

Facility Name

American Medical Research Institute

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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