TerminatedNot Applicable

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

Stopped: trouble with enrollment

United States15 participantsStarted 2017-05-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Urine microorganisms DNA analysis

Timeframe: Up to 14 days

Catheter microorganisms DNA analysis

Timeframe: Up to 14 days

Trial details

NCT IDNCT03176394

SponsorNext Science TM

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-10-18

View on ClinicalTrials.gov More Urinary Tract Infections trials