Phase 1
Completed N=10
Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study
Source: ClinicalTrials.gov NCT00554996 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Rate of UTI While Colonized With E. Coli 83972. — 8.5 UTIs per 1000 patient-days
Summary
This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of UTI While Colonized With E. Coli 83972. |
8.5 | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00554996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.