Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

T2 Biosystems

Status: Completed

Conditions: Candidemia

Study type: Observational

Funder types: Industry

Identifiers

NCT01525095

PRO-00030

Details and patient eligibility

About

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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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.

3. 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

1. Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
2. 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.

Trial design

700 participants in 2 patient groups

Candida Positive Patients

Description:

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

Description:

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