NCT01834391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

April 28, 2016

Status Verified

April 1, 2016

Enrollment Period

6 months

First QC Date

March 20, 2013

Last Update Submit

April 26, 2016

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Biomarker candidates for UTIs recalcitrant to antibiotic treatment.

    Nine months

  • Morbidity

    9 months

  • Mortality

    9 months

Study Arms (1)

Geriatric Traumatic Injury

Geriatric trauma pateints being admitted to Saint Marys Hosptial.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Prisoners
  • Pregnancy
  • Active urinary tract stones
  • Less than 65 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Martin Zielinski, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

March 20, 2013

First Posted

April 17, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2015

Last Updated

April 28, 2016

Record last verified: 2016-04

Locations

US(1)