NCT03176394

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Next Science TM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urinary Tract Infections

Interventions

Type	Name	Description
DEVICE	BLASTX Gel	Foley Catheter lubricated with BLASTX Gel
DEVICE	McKesson Jelly	Foley Catheter lubricated with McKesson Jelly

Timeline

• Start date: 2017-05-24
• Primary completion: 2019-10-18
• Completion: 2019-10-18
• First posted: 2017-06-05
• Last updated: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study