Host Response to Urinary Tract Infection in Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
ClinicalTrials.gov Identifier:
NCT00642070
First received: March 18, 2008
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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.


Condition
Urinary Tract Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Host Response to Urinary Tract Infection in Women

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Determine elements of the immune response that may predispose a woman to recurrent urinary tract infection [ Time Frame: 2017 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood,serum, urine


Enrollment: 326
Study Start Date: February 2008
Study Completion Date: July 2012
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642070

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

No publications provided

Responsible Party: Ann Stapleton, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00642070     History of Changes
Other Study ID Numbers: 31467-D, NIDDK 1 P50 AR049475-06;, 06-4836-D
Study First Received: March 18, 2008
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on July 20, 2014