- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01904188
Clinical Microbial Species & Antibiotic Resistance ID in ED Patients Presenting With Infection - is Rapid ID Possible & Accurate?
Clinical Microbial Species and Antibiotic Resistance Identification in Patients Presenting to the Emergency Department With Three of Four Systemic Inflammatory Response Syndrome (SIRS) Criteria - is Rapid Identification Possible and Accurate?
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mary J Hughes, DO
- Phone Number: 517-353-3211
- Email: hughesm@msu.edu
Study Contact Backup
- Name: Brett Etchebarne, MD PhD
- Phone Number: 517-353-3211
- Email: madcow@msu.edu
Study Locations
-
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Michigan
-
Lansing, Michigan, United States, 48909
- Recruiting
- Sparrow Health System
-
Contact:
- Brett Etchebarne, MD PhD
- Phone Number: 517-353-3211
- Email: madcow@msu.edu
-
Contact:
- Walid Khalife, PhD
- Phone Number: 517-364-2170
- Email: walid.khalife@sparrow.org
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Sub-Investigator:
- Brett Etchebarne, MD/PhD
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Sub-Investigator:
- Walid Khalife, PhD
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Principal Investigator:
- Mary J Hughes, DO
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Sub-Investigator:
- Syed A Hashsham, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Adult patients with 3 of 4 systemic inflammatory response syndrome (SIRS) characteristics (1. tachycardia, 2. fever or hypothermia, 3. tachypnea, 4. leukocytosis), who have blood cultures drawn and urine collected for the evaluation of suspected sepsis, and/or other bodily fluids collected for culture and sensitivity analysis.
Patients with other sources of infection with less than 3 of 4 SIRS criteria
Exclusion Criteria:
Pediatric patients
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
SIRS positive
Adult (> or = 18 years) patients with 3 of 4 systemic inflammatory response syndrome (SIRS) characteristics (1.
tachycardia, 2. fever or hypothermia, 3. tachypnea, 4. leukocytosis), who have blood cultures drawn and urine collected for the evaluation of suspected sepsis, along with any other bodily fluid suspected to be the source of infection.
May also include others without SIRS criteria but with bodily fluid production or infection of a bodily fluid
|
The Gene Z device or other rapid diagnostic techniques that we have developed in our lab will be used to analyze previously processed specimens for microbial organisms and compared to prior culture and sensitivity results.
It is not a separate arm - all samples will be cultured in lab per standard protocol and then the Gene Z device or other rapid diagnostic techniques developed in our lab will be used to re-analyze at a later date specimens that were previously frozen and stored and compared to culture results
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of microbial identification with culture results from clinical laboratory
Time Frame: up to six months per specimen
|
Frozen microbial specimens will be transported to an off site laboratory for analysis with the GeneZ or other point of care or rapid diagnostic technique or device, with investigators blinded to the final culture results of the specimen - positive or negative.
Comparison will be made between final culture result and GeneZ identification of organism or other method as developed in the investigators' lab.
|
up to six months per specimen
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbial Resistance Gene Pattern
Time Frame: up to one year per specimen
|
Frozen specimens will be transported to an offsite laboratory where real time PCR will be used to identify microorganism resistance gene patterns of organisms identified by the GeneZ device or other rapid diagnostic technique or point of care device.
These will be compared to the antibiotic sensitivity results from the culture and sensitivity reports done in the clinical laboratory.
|
up to one year per specimen
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mary J Hughes, DO, Michigan State University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Inflammation
- Disease Attributes
- Disease
- Bacterial Infections and Mycoses
- Shock
- Coronavirus Infections
- Syndrome
- Infections
- Communicable Diseases
- Mycoses
- Bacterial Infections
- Systemic Inflammatory Response Syndrome
Other Study ID Numbers
- C13-033F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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