Study Stopped
Funding Period ended, did not reach full sample size due to limited numbers of eligible patients
Computer-Assisted Treatment of Urinary Tract Infection in Emergency Departments and Community Health Centers
UTI-Kiosk
Computer-Assisted Treatment in the Management of Adult Female Patients With Symptoms of Urinary Tract Infection in Emergency Departments and Community Health Centers: A Randomized Trial
1 other identifier
interventional
200
1 country
5
Brief Summary
Our study aims to test the utility of computer-assisted treatment for uncomplicated, recurrent urinary tract infections (UTIs) for women receiving care in safety net health care facilities. As of November 2009, we are also testing the utility of computer-assisted treatment for certain types of complicated cystitis (i.e. women with voiding symptoms and one of the following complicating symptoms: fever, flank pain, or symptoms greater than 7 days).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Typical duration for not_applicable
5 active sites
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
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMarch 6, 2015
March 1, 2015
2.9 years
August 5, 2008
March 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of subjects with treatment failure or relapse
21 days
Secondary Outcomes (1)
Patient acceptability of treatment by computer
21 days
Study Arms (4)
Treatment Group 1 - uncomplicated UTI
EXPERIMENTALWould receive computer-assisted treatment for a uncomplicated UTI.
Control Group 1
ACTIVE COMPARATORQualified for expedited treatment for uncomplicated cystitis but would receive usual care in the Emergency Department of Community Health Center.
Treatment Group 2 - Complicated Cystitis
EXPERIMENTALWould receive expedited treatment for complicated cystitis with longer antibiotic course than the simple UTI patients.
Control Group 2
ACTIVE COMPARATORQualified for expedited treatment for complicated cystitis treatment but would receive usual care in the clinic or emergency department.
Interventions
This group will receive computer-assisted expedited treatment for uncomplicated UTI or complicated cystitis based on their symptoms and past medical history reported on the computer.
This group will receive usual care for an uncomplicated UTI or complicated cystitis in the Emergency Department or Community Health Center.
Eligibility Criteria
You may qualify if:
- Female
- years old
You may not qualify if:
- Below 18 or Above 64
- Male
- New flank pain
- severe vomiting
- High blood sugar or diabetes
- surgery on kidneys
- chronic kidney disease
- Previous cancer or chemotherapy
- HIV or AIDS
- pregnant or suspected pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
CMC Fresno Emergency Department
Fresno, California, 93701, United States
La Clinica
Oakland, California, 94601, United States
Highland Hospital Emergency Department
Oakland, California, 94602, United States
San Francisco General Hospital - Emergency Department
San Francisco, California, 94110, United States
UCSF Emergency Deparmtent
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ralph Gonzales, MD
University of California, San Francsico
- PRINCIPAL INVESTIGATOR
John Stein, MD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Bradley Frazee, MD
Alameda County Medical Centers, Highland Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 11, 2008
Study Start
August 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
March 6, 2015
Record last verified: 2015-03