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

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ClinicalTrials.gov Identifier: NCT00554996
Recruitment Status : Completed
First Posted : November 7, 2007
Results First Posted : September 16, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Urinary Tract Infection
Intervention: Device: E. coli 83972 coated urinary catheter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
E. Coli 83972 Coated Urinary Catheter E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter

Participant Flow:   Overall Study
    E. Coli 83972 Coated Urinary Catheter
STARTED   10 
COMPLETED   10 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
See Eligibility section.

Reporting Groups
  Description
E. Coli 83972 Coated Urinary Catheter E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter

Baseline Measures
   E. Coli 83972 Coated Urinary Catheter 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Years]
Mean (Full Range)
 70.9 
 (58 to 88) 
Gender 
[Units: Participants]
 
Female   2 
Male   8 


  Outcome Measures

1.  Primary:   Rate of UTI While Colonized With E. Coli 83972.   [ Time Frame: 0-266 days of colonization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our trial was a small study with no control group.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Barbara Trautner, MD, PhD
Organization: Barbara Trautner, MD, PhD
phone: 713-440-4438
e-mail: barbara.trautner@va.gov


Publications of Results:
Other Publications:


Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00554996     History of Changes
Other Study ID Numbers: B4623-R
First Submitted: November 5, 2007
First Posted: November 7, 2007
Results First Submitted: July 16, 2015
Results First Posted: September 16, 2015
Last Update Posted: October 16, 2015