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Trial Outcomes & Findings for Bacterial Interference for Prevention of Catheter-Associated UTI: Geriatric Pilot Study (NCT NCT00554996)

NCT ID: NCT00554996

Last Updated: 2015-10-16

Results Overview

Rate of UTI during colonization with E. coli 83972.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

0-266 days of colonization

Results posted on

2015-10-16

Participant Flow

Participant milestones

Participant milestones
Measure
E. Coli 83972 Coated Urinary Catheter
E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
E. Coli 83972 Coated Urinary Catheter
n=10 Participants
E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Age, Continuous
70.9 years
n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 0-266 days of colonization

Population: Number of UTIs per 1000 patient-days during colonization with E. coli 83972.

Rate of UTI during colonization with E. coli 83972.

Outcome measures

Outcome measures
Measure
E. Coli 83972 Coated Urinary Catheter
n=10 Participants
E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Rate of UTI While Colonized With E. Coli 83972.
8.5 UTIs per 1000 patient-days

Adverse Events

E. Coli 83972 Coated Urinary Catheter

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
E. Coli 83972 Coated Urinary Catheter
n=10 participants at risk
E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
Renal and urinary disorders
Febrile UTI or Urosepsis/bacteremia
50.0%
5/10 • Number of events 5

Additional Information

Barbara Trautner, MD, PhD

Barbara Trautner, MD, PhD

Phone: 713-440-4438

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place