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

NCT00927316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-11-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Coloplast A/S

    collaborator INDUSTRY

  • Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden

    collaborator UNKNOWN

  • Swedish Institute for Infectious Disease Control

    collaborator OTHER

  • Lund University Hospital

    collaborator OTHER

  • Region Skane

    lead OTHER

Principal Investigators

  • Fredrik Sundén, MD · Dept. of Urology, University Hospital, 221 85 Lund

  • Björn Wullt, MD, PhD · Dept. of Urology, Lund University Hospital, 221 85 Lund

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927316 on ClinicalTrials.gov