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

NCT03176394 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-11-07

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

BLASTX Gel

Foley Catheter lubricated with BLASTX Gel

DEVICE

McKesson Jelly

Foley Catheter lubricated with McKesson Jelly

Sponsors & Collaborators

  • Next Science TM

    lead INDUSTRY

Principal Investigators

  • Susan Greco, MD · Next Science

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2019-10-18
Completion
2019-10-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03176394 on ClinicalTrials.gov