E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in P... | NCT00927316

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

NCT00927316

Sponsor

Region Skane

Status

Completed

Last Update Posted

Nov 10, 2009Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Urinary Tract Infection

Interventions

E. coli 83972

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Jun 22, 2009

First Submission Date that Met QC Criteria

Jun 23, 2009

First Posted Date

Jun 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2009

Last Update Posted Date

Nov 10, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Region SkaneOTHER

Collaborators

Name	Class
Coloplast A/S	INDUSTRY
Riksförbundet för Trafik, Olycksfall och Polioskadade (RTP), Sundbyberg, Sweden	UNKNOWN
Swedish Institute for Infectious Disease Control	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active arm	Active Comparator	E. coli 83972 bacteriuria	Biological: E. coli 83972
Placebo arm	Placebo Comparator	Monitoring	Biological: E. coli 83972

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E. coli 83972	Biological	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to UTI		12 months
Number of UTI		During 12 months placebo or active treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fredrik Sundén, MD	Dept. of Urology, University Hospital, 221 85 Lund	Principal Investigator
Björn Wullt, MD, PhD	Dept. of Urology, Lund University Hospital, 221 85 Lund	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Lund University		Lund		SE-221 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided