Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01525095

Acronym

DIRECT

Enrollment

700

Registered

2012-02-02

Start date

2012-01-31

Completion date

2014-03-31

Last updated

2014-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Candidemia

Keywords

Candida, Diagnostic Assay, Blood culture, Sepsis, T2 Magnetic Relaxation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 95 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Candida Positive patients	3-5 days post blood culture	Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal

Secondary

Measure	Time frame	Description
Number of Candida Negative Patients	3-5 days post blood culture	Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal

Countries

United States

Outcome results