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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
J. Craig Venter Institute
Information provided by (Responsible Party):
Martin D. Zielinski, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01834391
First received: March 20, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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
Urinary Tract Infection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Identify of bacteria, genes and proteins that are highly predictive of UTI development [ Time Frame: Nine months ] [ Designated as safety issue: No ]
    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:
  • Biomarker candidates for UTIs recalcitrant to antibiotic treatment. [ Time Frame: Nine months ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Urine


Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Geriatric Traumatic Injury
Geriatric trauma pateints being admitted to Saint Marys Hosptial.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Geriatric traumatic injury patients that were admitted to Saint Marys Hospital.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834391

Locations
United States, Minnesota
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
  More Information

No publications provided

Responsible Party: Martin D. Zielinski, Assistant Professor of Surgery, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01834391     History of Changes
Other Study ID Numbers: 12-010185
Study First Received: March 20, 2013
Last Updated: January 29, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 21, 2014