Trials / Completed
CompletedNCT01919762
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)
Detecting Infections Rapidly and Easily for Bacteremia Trial (DIREBT)-Part I (Prospective Collection and Freezing of Whole Blood Specimens)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 156 (actual)
- Sponsor
- T2 Biosystems · Industry
- Sex
- All
- Age
- 18 Years – 95 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Timeline
- Start date
- 2013-08-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2013-08-09
- Last updated
- 2015-09-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01919762. Inclusion in this directory is not an endorsement.