NCT00642070

Brief Summary

This study is being done to identify those elements of the immune response that may predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness of certain components of the host response will lead to recurrent urinary tract infection. We will also evaluate the role that the bladder reservoir may play in recurrent urinary tract infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

4.4 years

First QC Date

March 18, 2008

Last Update Submit

June 3, 2014

Conditions

Urinary Tract Infection

Keywords

Current symptoms of urinary tract infection

Outcome Measures

Primary Outcomes (1)

  • Determine elements of the immune response that may predispose a woman to recurrent urinary tract infection

    2017

Study Arms (1)

Host

Women with current symptoms of a urinary tract infection

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women between the ages of 18-49 with symptoms of a urinary tract infection for fewer than 7 days

You may qualify if:

  • Female
  • Age 18-49 years
  • Able to provide written informed consent
  • diagnosis of acute cystitis with symptoms for fewer than 7 days

You may not qualify if:

  • Not pregnant or planning pregnancy in next 3 months
  • No chronic illness requiring medical supervision (e.g. diabetes mellitus)
  • No known anatomic or functional abnormalities of the urinary tract
  • No signs or symptoms suggestive of pyelonephritis (flank pain or tenderness, temperature over 100 degrees F, nausea or vomiting)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington/Hall Health Primary Care Center

Seattle, Washington, 98195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood,serum, urine

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ann E Stapleton, M.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

February 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

US(1)