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Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study

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ClinicalTrials.gov Identifier: NCT00554996
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Urinary Tract Infection
Intervention Device: E. coli 83972 coated urinary catheter
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E. Coli 83972 Coated Urinary Catheter
Hide Arm/Group Description E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title E. Coli 83972 Coated Urinary Catheter
Hide Arm/Group Description E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
See Eligibility section.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
70.9
(58 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
1.Primary Outcome
Title Rate of UTI While Colonized With E. Coli 83972.
Hide Description Rate of UTI during colonization with E. coli 83972.
Time Frame 0-266 days of colonization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of UTIs per 1000 patient-days during colonization with E. coli 83972.
Arm/Group Title E. Coli 83972 Coated Urinary Catheter
Hide Arm/Group Description:
E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: UTIs per 1000 patient-days
8.5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E. Coli 83972 Coated Urinary Catheter
Hide Arm/Group Description E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
All-Cause Mortality
E. Coli 83972 Coated Urinary Catheter
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
E. Coli 83972 Coated Urinary Catheter
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E. Coli 83972 Coated Urinary Catheter
Affected / at Risk (%) # Events
Total   5/10 (50.00%)    
Renal and urinary disorders   
Febrile UTI or Urosepsis/bacteremia *  5/10 (50.00%)  5
*
Indicates events were collected by non-systematic assessment
Our trial was a small study with no control group.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Barbara Trautner, MD, PhD
Organization: Barbara Trautner, MD, PhD
Phone: 713-440-4438
Other Publications:
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00554996     History of Changes
Other Study ID Numbers: B4623-R
First Submitted: November 5, 2007
First Posted: November 7, 2007
Results First Submitted: July 16, 2015
Results First Posted: September 16, 2015
Last Update Posted: October 16, 2015