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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01834391
Collaborator
J. Craig Venter Institute (Other)
129
Enrollment
1
Location
30
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    129 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2013
    Actual Study Completion Date :
    Sep 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Geriatric Traumatic Injury

    Geriatric trauma pateints being admitted to Saint Marys Hosptial.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Biomarker candidates for UTIs recalcitrant to antibiotic treatment. [Nine months]

    2. Morbidity [9 months]

    3. Mortality [9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • J. Craig Venter Institute

    Investigators

    • Principal Investigator: Martin Zielinski, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Martin D. Zielinski, Assistant Professor of Surgery, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT01834391
    Other Study ID Numbers:
    • 12-010185
    First Posted:
    Apr 17, 2013
    Last Update Posted:
    Apr 28, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Urinary Tract Infections

    Study Results

    No Results Posted as of Apr 28, 2016