Efficacy of BLASTX in Catheter Associated Bacteriuria Versus Standard of Care (SOC)
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|ClinicalTrials.gov Identifier: NCT03176394|
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infections||Device: BLASTX Gel Device: McKesson Jelly||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|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|
|Actual Study Start Date :||May 24, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: BLASTX Lubricated Catheter
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
Foley Catheter lubricated with BLASTX Gel
Placebo Comparator: McKesson Jelly Lubricated Catheter
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 McKesson Jelly
- Urine microorganisms DNA analysis [ Time Frame: Up to 14 days ]Change in microorganisms in the test group compared to the control group.
- Catheter microorganisms DNA analysis [ Time Frame: Up to 14 days ]Change in microorganisms in the test group compared to the control group.
- Incidence of Urinary Tract Infections (UTIs) [ Time Frame: 14 days ]Number of instances of clinically symptomatic UTI in the test versus the control group
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176394
|Contact: Valerie Hayes, PhDfirstname.lastname@example.org|
|Contact: Michael McDonald, MDemail@example.com|
|United States, Florida|
|American Medical Research Institute||Recruiting|
|Celebration, Florida, United States, 34747|
|Contact: Michael McDonald, MD 407-405-3443 firstname.lastname@example.org|
|Contact: Tatiana Vasquez, MA 407-764-4079 ext 3 Tatiana.Vazquez@flhosp.org|
|Study Director:||Matt Myntti, PhD||Next Science|