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The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candida Positive Patients | Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive | ||
| Candida Negative Patients | Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Candida Positive patients | Number of Candida 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 Candida Negative Patients | Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal | 3-5 days post blood culture |
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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.
For Group A,
For Group B,
Exclusion Criteria:
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Adult patients who have undergone a diagnostic blood culture.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Pappas, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0006 | United States | ||
| University of California San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29438475 | Derived | Clancy CJ, Pappas PG, Vazquez J, Judson MA, Kontoyiannis DP, Thompson GR 3rd, Garey KW, Reboli A, Greenberg RN, Apewokin S, Lyon GM 3rd, Ostrosky-Zeichner L, Wu AHB, Tobin E, Nguyen MH, Caliendo AM. Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel. Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095. | |
| 23315320 |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| C536972 | Torulopsis |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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Whole Blood specimens, in addition to bacterial and fungal species isolates
| San Francisco |
| California |
| 94110 |
| United States |
| University of Kentucky | Lexington | Kentucky | 40536-0298 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| University of Houston College of Pharmacy | Houston | Texas | 77030 | United States |
| Derived |
| Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11. |
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |