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

Completed

• Conditions: Urinary Tract Infection

• Registration Number: NCT01834391
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Primary Completion: 2013-09
• Study Completion: 2015-09
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify of bacteria, genes and proteins that are highly predictive of UTI development	Nine months	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.

Secondary Outcome Measures

Name	Time	Method
Biomarker candidates for UTIs recalcitrant to antibiotic treatment.	Nine months
Morbidity	9 months
Mortality	9 months

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States