Study Stopped
trouble with enrollment
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
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
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 24, 2017
CompletedFirst Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedNovember 7, 2023
November 1, 2023
2.4 years
May 30, 2017
November 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Urine microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Up to 14 days
Catheter microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Up to 14 days
Secondary Outcomes (1)
Incidence of Urinary Tract Infections (UTIs)
14 days
Study Arms (2)
BLASTX Lubricated Catheter
EXPERIMENTALSubjects 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.
McKesson Jelly Lubricated Catheter
PLACEBO COMPARATORSubjects 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Next Science TMlead
Study Sites (1)
American Medical Research Institute
Celebration, Florida, 34747, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Susan Greco, MD
Next Science
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 5, 2017
Study Start
May 24, 2017
Primary Completion
October 18, 2019
Study Completion
October 18, 2019
Last Updated
November 7, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share