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E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

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ClinicalTrials.gov Identifier: NCT00927316
Recruitment Status : Completed
First Posted : June 24, 2009
Last Update Posted : November 10, 2009
Sponsor:
Collaborators:
Coloplast A/S
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
Swedish Institute for Infectious Disease Control
Lund University Hospital
Information provided by:
Region Skane

Brief Summary:
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Biological: E. coli 83972 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.
Study Start Date : March 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active arm
E. coli 83972 bacteriuria
Biological: E. coli 83972

Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).

Placebo arm: Identical procedure but with saline, 30 ml.

Placebo Comparator: Placebo arm
Monitoring
Biological: E. coli 83972

Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml).

Placebo arm: Identical procedure but with saline, 30 ml.




Primary Outcome Measures :
  1. Time to UTI [ Time Frame: 12 months ]
  2. Number of UTI [ Time Frame: During 12 months placebo or active treatment ]


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent UTI
  • Bladder emptying dysfunction
  • Optimal conservative treatment incl. clean intermittent catheterization
  • Capable of "self reporting of UTI episodes"

Exclusion Criteria:

  • Malignant disease
  • Immunosuppression
  • Recurrent pyelonephritis
  • Abnormalities within upper urinary tract, including renal stones and poor kidney function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00927316


Locations
Sweden
Department of Urology, Lund University
Lund, Sweden, SE-221 85
Sponsors and Collaborators
Region Skane
Coloplast A/S
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden
Swedish Institute for Infectious Disease Control
Lund University Hospital
Investigators
Principal Investigator: Fredrik Sundén, MD Dept. of Urology, University Hospital, 221 85 Lund
Study Chair: Björn Wullt, MD, PhD Dept. of Urology, Lund University Hospital, 221 85 Lund

Responsible Party: Fredrik Sundén, MD, Dept. of Urology, University Hospital, Lund, Sweden
ClinicalTrials.gov Identifier: NCT00927316     History of Changes
Other Study ID Numbers: RTP-A2003
First Posted: June 24, 2009    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Region Skane:
Report of Urinary Tract Infection episode

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Bacteriuria
Urologic Diseases