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The objective of this study is to investigate T2Candida performance as a monitoring tool for post-therapy clearance of Candida compared to blood culture.
This study will collect a T2clinical specimen and companion blood culture from patients who have exhibited a positive blood culture by gram stain for yeast, and who are receiving treatment with antifungal therapy.
One blood culture and one set of T2clinical specimens will be collected at specified intervals to monitor the clearance of Candida infection from the bloodstream.
Each T2 result will be compared to the companion blood culture result. The comparison will determine if the presence of antifungal therapy inhibits blood culture and leads to an incidence of blood culture false negative test results. The T2 result, which is not impacted by the presence of antifungal therapy, can show that the pathogen is still present for some additional period of time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Candida Positive Patients | Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to negative test result | The number of days to a negative test result will be compared between the T2Candida Test and blood culture. | 14 days post enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients receiving treatment with antifungal therapy for 1 of 5 Candida species:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-2030 | United States | ||
| University of Pittsburgh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29367293 | Derived | Mylonakis E, Zacharioudakis IM, Clancy CJ, Nguyen MH, Pappas PG. Efficacy of T2 Magnetic Resonance Assay in Monitoring Candidemia after Initiation of Antifungal Therapy: the Serial Therapeutic and Antifungal Monitoring Protocol (STAMP) Trial. J Clin Microbiol. 2018 Mar 26;56(4):e01756-17. doi: 10.1128/JCM.01756-17. Print 2018 Apr. |
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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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At each time point, three 4 ml whole blood specimens will be collected. One sample will be tested, and the remaining samples will be available for use in investigating discrepant T2Candida assay and blood culture results, or may be used for research purposes
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |