Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03176394
Status:
TERMINATED
Last Update Posted:
2023-11-07
First Post:
2017-05-30
Brief Title:
Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care SOC
Sponsor:
Next Science TM
Organization:
Next Science TM
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 11 to either the biofilm disrupting gel BLASTX or SOC McKesson Jelly lubricated catheters Urine andor 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 11 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:
None
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?:
None