Host Response to Urinary Tract Infection in Women

Urinary Tract Infection Clinical Trial

Official title:

Host Response to Urinary Tract Infection in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642070
• Other study ID #: 31467-D
• Secondary ID: NIDDK 1 P50 AR04
• Status: Completed
• Phase: N/A
• First received: March 18, 2008
• Last updated: June 3, 2014
• Start date: February 2008
• Est. completion date: July 2012

Study information

• Verified date: June 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	University of Washington/Hall Health Primary Care Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine elements of the immune response that may predispose a woman to recurrent urinary tract infection		2017	No