Phase 1 N=10 Prevention

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

Urinary Tract Infection

Bottom Line

View on ClinicalTrials.gov: NCT00554996 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2015

Primary outcome: Primary: Rate of UTI While Colonized With E. Coli 83972. — 8.5 UTIs per 1000 patient-days

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: E. coli 83972 coated urinary catheter (Device)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: US Department of Veterans Affairs
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of UTI While Colonized With E. Coli 83972.	8.5	—

Summary

This study is a prospective pilot clinical trial investigating the use of urinary catheters coated with benign E. coli in geriatric subjects.

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

View full record on ClinicalTrials.gov →

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.