Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT03176394
Status:
TERMINATED
Last Update Posted:
2023-11-07
First Post:
2017-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
Sponsor:
Next Science TM
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
trouble with enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: