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Molecular Diagnostic Test
Rectal swab collection for Enterobacteriaceae
N/A
Waitlist Available
Research Sponsored by Meridian Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial will compare a new test for detecting Carbapenemase Producing Organisms (CPOs) to the current standard method.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Performance characteristics : Clinical sensitivity (true positive rate) in comparison to the Reference Method
Performance characteristics : clinical specificity (true negative rate) in comparison to the Reference Method
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: revogene TestingExperimental Treatment1 Intervention
The swab will be used for the testing on the revogene using the GenePOC Carba assay.
Group II: Reference MethodActive Control1 Intervention
The other swab will be used in the Reference Method.
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Who is running the clinical trial?
Meridian Bioscience, Inc.Lead Sponsor
32 Previous Clinical Trials
11,549 Total Patients Enrolled
Keith Chiasson, PhDStudy DirectorMeridian Bioscience, Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for participants in this research experiment?
"The clinical trial database maintained by clinicialtrials.gov attests that this medical study is not presently seeking out any more participants; the initial entry was made on February 12th, 2019 and last updated April 29th 2021. Nevertheless, there are 1 other studies actively enrolling patients at present."
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