An interventional study of BLASTX Gel and McKesson Jelly in Urinary Tract Infections, sponsored by Next Science TM. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Next Science TM · Not applicable, Interventional, and Basic science
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.
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.
Exclusion Criteria:
Subjects 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.
Device: BLASTX Gel
Subjects 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.
Device: McKesson Jelly
Foley Catheter lubricated with BLASTX Gel
Foley Catheter lubricated with McKesson Jelly
Urine microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Time frame: Up to 14 days
Catheter microorganisms DNA analysis
Change in microorganisms in the test group compared to the control group.
Time frame: Up to 14 days
Incidence of Urinary Tract Infections (UTIs)
Number of instances of clinically symptomatic UTI in the test versus the control group
Time frame: 14 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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