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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)|
- Number of bacteremia positive patients [ Time Frame: 3-5 days post blood culture ] [ Designated as safety issue: No ]Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal
- Number of bacteremia negative patients [ Time Frame: 3-5 Days post blood culture ] [ Designated as safety issue: No ]Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal
Biospecimen Retention: Samples With DNA
Whole blood specimens, in addition to bacterial isoaltes
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Bacteremia Positive Patients
Symptomatic adult patients, confirmed via diagnostic blood culture and species identification followed by subsequent second blood culture results and species identification that are positive for each of the following species of bacteria (Target 6 Species).
Bacteremia Negative Patients
Adult patients confirmed via diagnostic blood culture and species identification and subsequent second blood culture and species identification as being negative for the Target 6 species
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919762
|United States, New Jersey|
|Cooper Medical School||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Mary Pileggi 856-757-9783 firstname.lastname@example.org|
|Principal Investigator: Annette Reboli, MD|