Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00554996 |
Recruitment Status :
Completed
First Posted : November 7, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Urinary Tract Infection | Device: E. coli 83972 coated urinary catheter | Phase 1 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 10 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Bacterial Interference for Prevention of Catheter-Associated UTI |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
E. coli 83972 coated urinary catheter
E. coli 83972 coated urinary catheter
|
Device: E. coli 83972 coated urinary catheter
E. coli 83972 coated urinary catheter |
- Rate of UTI While Colonized With E. Coli 83972. [ Time Frame: 0-266 days of colonization ]Rate of UTI during colonization with E. coli 83972.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients followed at the MEDVAMC
- Require an indwelling bladder catheter (either transurethral or suprapubic)
- Have a history of at least 1 UTI in the past will be eligible for enrollment
- Have pre-existing bladder colonization
Exclusion Criteria:
- obstructive urolithiasis
- percutaneous nephrostomy catheters
- supravesicular urinary diversion
- vesicoureteral reflux
- active malignancy
- uncontrolled diabetes mellitus
- AIDS
- requirement for immunosuppressive medication, expected survival < 6 months, creatinine clearance > 2.0 mg/dL, or current antibiotic therapy
- Latex allergy
- Allergic to 2 or more classes of drugs to which the urinary isolate is susceptible
- Prostate cancer on hormonal therapy with or without any surgery or radiation therapy anticipated within the next 6 months
- Prisoners
- Significant known mental illness or emotional disorder related to organic or inorganic causes
- subjects who are not capable of giving informed consent will not be included unless the subject's designated decision-maker is readily available

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): NCT00554996
United States, Texas | |
Michael E. DeBakey VA Medical Center, Houston, TX | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Barbara Trautner, MD | Michael E. DeBakey VA Medical Center, Houston, TX |
Other Publications:
Responsible Party: | US Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00554996 |
Other Study ID Numbers: |
B4623-R |
First Posted: | November 7, 2007 Key Record Dates |
Results First Posted: | September 16, 2015 |
Last Update Posted: | October 16, 2015 |
Last Verified: | September 2015 |
urinary tract infection urinary catheter Escherichia coli biofilm |
Urinary Tract Infections Infection Urologic Diseases |