Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients

Urinary Tract Infection Clinical Trial

Official title:

Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834391
• Other study ID #: 12-010185
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: April 26, 2016
• Start date: March 2013
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to see if the investigators can identify early those patients who are admitted to the hospital and have a urinary tract infection (UTI) or those patients that develop a UTI during their hospitalization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years old or older admitted as a result of trauma to Saint Marys Hospital at Mayo Clinic

Exclusion Criteria:

• Prisoners

• Pregnancy

• Active urinary tract stones

• Less than 65 years of age

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	J. Craig Venter Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify of bacteria, genes and proteins that are highly predictive of UTI development	To identify which bacteria, genes and proteins will be highly predictive of UTI development in geriatric trauma patients. We hypothesize that the combination of 16S rDNA and metaproteomics will identify the most informative biosignatures (species/genes/proteins) discerning UTI from asymptomatic bacteriuria.	Nine months	No
Secondary	Biomarker candidates for UTIs recalcitrant to antibiotic treatment.		Nine months	No
Secondary	Morbidity		9 months	No
Secondary	Mortality		9 months	Yes