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Completed

NCT Number: NCT01525095

Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)

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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Key information

Conditions

Candidemia Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Torulopsis

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Candida Positive patients

    Time frame: 3-5 days post blood culture

    Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal

Secondary outcomes

  1. Number of Candida Negative Patients

    Time frame: 3-5 days post blood culture

    Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal

Sponsors and collaborators

Lead sponsor

T2 Biosystems

Industry

Registry information

Official study title

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

Acronym: DIRECT

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Feb 2, 2012
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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