Host Response to Urinary Tract Infection in Women

NCT ID: NCT00642070

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2012-07-31

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.

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.

Conditions

Urinary Tract Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Host

Women with current symptoms of a urinary tract infection

No interventions assigned to this group

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ann Stapleton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ann E Stapleton, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington/Hall Health Primary Care Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

NIDDK 1 P50 AR049475-06;

Identifier Type: -

Identifier Source: secondary_id

06-4836-D

Identifier Type: OTHER

Identifier Source: secondary_id

31467-D

Identifier Type: -

Identifier Source: org_study_id