Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)

Conditions
-----------------
Candidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
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, Males and females 18 - 95 years of age. Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification. For Group B, Males and females 18 - 95 years of age. Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification. Exclusion Criteria: Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Candida Positive Patients<br>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<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida, Diagnostic Assay, Blood culture, Sepsis, T2 Magnetic Relaxation