Clinical trial NCT01525095: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
Official title: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidemia
Keywords: Candida
Diagnostic Assay
Blood culture
Sepsis
T2 Magnetic Relaxation
Lead sponsor: T2 Biosystems
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have undergone a diagnostic blood culture.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Candida Positive patients
timeFrame: 3-5 days post blood culture
Secondary outcomes:
measure: Number of Candida Negative Patients
timeFrame: 3-5 days post blood culture
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Houston
country: United States
facility: University of Houston College of Pharmacy
state: Texas
Study officials:
affiliation: University of Alabama at Birmingham
name: Peter Pappas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clancy CJ, Pappas PG, Vazquez J, Judson MA, Kontoyiannis DP, Thompson GR 3rd, Garey KW, Reboli A, Greenberg RN, Apewokin S, Lyon GM 3rd, Ostrosky-Zeichner L, Wu AHB, Tobin E, Nguyen MH, Caliendo AM. Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel. Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095.
citation: Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.