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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00446732 |
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Date of registration:
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11/03/2007 |
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Primary sponsor: |
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Public title:
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The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
CAUTI |
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Scientific title:
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Catheter Associated Urinary Tract Infections |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00446732 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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Countries of recruitment
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Israel
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Contacts
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Name:
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Ofer Shenfeld, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Ofer Shenfeld, MD |
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Address:
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Telephone:
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972-2-6555560 |
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Email:
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shenfeld@szmc.org.il |
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Affiliation:
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Name:
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Ofer Shenfeled, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sharei Zedek |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hospitalized patients age 18 years or older
- Patients requiring or having catheterization for more than 24 hours
- Patient able, agrees and signs the Informed Consent Form
Exclusion Criteria:
- Pregnant or breastfeeding women. Women of child bearing potential will perform a
pregnancy test before inclusion into the study
- Presence of any clinically relevant known urinary tract infection
- Patient with condition who is not expected to survive the study period
- Known HIV positive
- Patient has any condition, which precludes compliance with study and/or device
instructions.
- Patient is currently participating in another clinical study.
- Known allergy to latex
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Urinary Tract Infection
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Intervention(s)
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Device: UroSshield
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Primary Outcome(s)
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primary end points
[Time Frame: up to 14 days]
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Secondary ID(s)
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US-71-003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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