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Host Response to Urinary Tract Infection in Women
This study is currently recruiting participants.
Verified by University of Washington, March 2009
First Received: March 18, 2008   Last Updated: March 3, 2009   History of Changes
Sponsors and Collaborators: University of Washington
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00642070
  Purpose

This study is being done to identify those elements of the immune response that my 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.


Condition
Urinary Tract Infection

MedlinePlus related topics: Urinary Tract Infections
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Host Response to Urinary Tract Infection in Women

Further study details as provided by University of Washington:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

whole blood,serum, urine


Estimated Enrollment: 350
Study Start Date: February 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Host
Women with current symptoms of a urinary tract infection

Detailed Description:

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of urinary tract infection. They will be asked to provide a clean catch urine sample. We will collect periurethral, vaginal and rectal swabs. Blood will collected. They will be given a diary to take home and record all episodes of sexual intercourse, contraceptive use, vaginal and urinary symptoms and medication use.

They will be given standard treatment for the current urinary tract infection. Follow-up visits will be scheduled 2 weeks,one month,two month and three month after initial visit.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642070

Contacts
Contact: Niki DeShaw, Coord 206-685-1048 ndeshaw@u.washington.edu
Contact: Ellen Cassen, ARNP 206-685-1048 ecassen@u.washington.edu

Locations
United States, Washington
University of Washington/Hall Health Primary Care Center Recruiting
Seattle, Washington, United States, 98195
Principal Investigator: Walter E Stamm, M.D.            
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Walter E Stamm, M.D. University of Washington
  More Information

No publications provided

Responsible Party: University of Washington ( Walter E. Stamm, MD )
Study ID Numbers: 31467-D, NIDDK 1 P50 AR049475-06;, 06-4836-D
Study First Received: March 18, 2008
Last Updated: March 3, 2009
ClinicalTrials.gov Identifier: NCT00642070     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Current symptoms of urinary tract infection

Study placed in the following topic categories:
Urologic Diseases
Urinary Tract Infections

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

ClinicalTrials.gov processed this record on May 07, 2009