Status:
COMPLETED
T2Resistance - Detection of Resistance Related Genes
Lead Sponsor:
T2 Biosystems
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Resistance Bacterial
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1. Prospective arm: positive percent agreement ...
Detailed Description
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1. Prospective arm: positive percent agreement ...
Eligibility Criteria
Inclusion
- Prospective Arm:
- Obtain informed consent according to institutional requirements, as needed.
- Patient has had a diagnostic blood culture ordered per routine standard of care.
- Patient is 18 years of age or older.
Exclusion
- Prospective Arm
- Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the patient's ability to participate in the study or impact the scientific integrity of the study.
- Patient has had previous specimens tested for the T2Resistance Panel with valid results.
Key Trial Info
Start Date :
January 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 24 2024
Estimated Enrollment :
1566 Patients enrolled
Trial Details
Trial ID
NCT05231187
Start Date
January 21 2022
End Date
April 24 2024
Last Update
December 19 2024
Active Locations (10)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 352494
2
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
Ochsner Medical Center
New Orleans, Louisiana, United States, 70121