Status:
COMPLETED
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
Lead Sponsor:
T2 Biosystems
Conditions:
Bacteremia
Eligibility:
All Genders
18-95 years
Brief Summary
To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
Detailed Description
This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical hi...
Eligibility Criteria
Inclusion
- Subject or subject's authorized representative must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- Males and females 18 - 95 years of age.
- For Group A,
- Subject is confirmed to have bacteremia (gram negative rods, gram negative coccobacillus, and/or gram positive cocci) as evidenced by a positive diagnostic blood culture
- Subsequent species identification identifies the presence of one of the following 6 species of bacteria:
- Acinetobacter baumannii
- Staphylococcus aureus
- Klebsiella pneumonia
- Pseudomonas aeruginosa
- Enterococcus faecalis
- Enterococcus faecium
- For Group B,
- Males and females 18 - 95 years of age.
- Subject is confirmed to not have bacteremia from the 6 bacteria species targeted by this study, as evidenced by diagnostic blood culture and subsequent species identification.
Exclusion
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- Subject has had an anti-bacterial drug administered through the same port or central line as is used to collect the clinical research specimens. A line draw cannot be used to obtain a study sample if an antibacterial agent was administered intravenously within the last 72 hours, unless the site can specifically document that a different line was used to administer the anti-bacterial agent.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01919762
Start Date
August 1 2013
End Date
August 1 2015
Last Update
September 28 2015
Active Locations (1)
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1
Cooper Medical School
Camden, New Jersey, United States, 08103