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Phase 1 Completed N=10 Prevention

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

OutcomeResultp-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
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. Informational only — not medical advice.

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