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Trial record 70 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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
Sponsor:
Collaborator:
American Medical Research Institute
Information provided by (Responsible Party):
Next Science TM

Brief 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Device: BLASTX Gel Device: McKesson Jelly Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Urine microorganisms DNA analysis [ Time Frame: Up to 14 days ]
    Change in microorganisms in the test group compared to the control group.

  2. Catheter microorganisms DNA analysis [ Time Frame: Up to 14 days ]
    Change in microorganisms in the test group compared to the control group.


Secondary Outcome Measures :
  1. Incidence of Urinary Tract Infections (UTIs) [ Time Frame: 14 days ]
    Number of instances of clinically symptomatic UTI in the test versus the control group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years or older
  2. Absence of symptomatic UTI
  3. Absence of upper/lower tract obstructions
  4. No known allergies to the study products
  5. Willing to comply with all study procedures and available for the duration of the study

Exclusion Criteria:

  1. 17 years or younger
  2. Symptomatic UTI
  3. Presence of upper/lower tract obstructions
  4. Known allergic reaction to the study products
  5. Unable to provide signed and dated informed consent form

Information from the National Library of Medicine

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


Contacts
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Contact: Valerie Hayes, PhD 9048647579 vhayes.phd@gmail.com
Contact: Michael McDonald, MD 4074053443 uccf40@yahoo.com

Locations
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United States, Florida
American Medical Research Institute Recruiting
Celebration, Florida, United States, 34747
Contact: Michael McDonald, MD    407-405-3443    uccf40@yahoo.com   
Contact: Tatiana Vasquez, MA    407-764-4079 ext 3    Tatiana.Vazquez@flhosp.org   
Sponsors and Collaborators
Next Science TM
American Medical Research Institute
Investigators
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Study Director: Matt Myntti, PhD Next Science

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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT03176394     History of Changes
Other Study ID Numbers: CSP-005
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Next Science TM:
Foley, UTI, Biofilm, DNA

Additional relevant MeSH terms:
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Urinary Tract Infections
Bacteriuria
Infection
Urologic Diseases