Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of bacteremia positive patients | Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal | 3-5 days post blood culture |
| Measure | Description | Time Frame |
|---|---|---|
| Number of bacteremia negative patients | Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal | 3-5 Days post blood culture |
Not provided
Inclusion Criteria:
For Group A,
For Group B,
Exclusion Criteria:
Not provided
Not provided
Patients with blood culture results are eligible to participate
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper Medical School | Camden | New Jersey | 08103 | United States |
Not provided
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| D013203 | Staphylococcal Infections |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood specimens, in addition to bacterial isoaltes
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016908 | Gram-Positive Bacterial Infections |
| D016905 | Gram-Negative Bacterial Infections |