Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
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.
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 history, blood properties, medications, and blood culture history/results
 are required from the T2Bacterial Assay's target patient population (i.e., candidates for
 blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will
 be collected from negative blood culture, positive non-bacteria blood culture and positive
 bacteria blood culture patients.
Inclusion Criteria:

 -  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 Criteria:

 -  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.