NCT01525095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

June 9, 2014

Status Verified

June 1, 2014

Enrollment Period

1.9 years

First QC Date

January 25, 2012

Last Update Submit

June 6, 2014

Conditions

Candidemia

Keywords

CandidaDiagnostic AssayBlood cultureSepsisT2 Magnetic Relaxation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Candida Negative Patients

    3-5 days post blood culture

Study Arms (2)

Candida Positive Patients

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

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

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who have undergone a diagnostic blood culture.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

University of California San Francisco

San Francisco, California, 94110, United States

Location

University of Kentucky

Lexington, Kentucky, 40536-0298, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

University of Houston College of Pharmacy

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • 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.

    PMID: 29438475DERIVED

  • 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.

    PMID: 23315320DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood specimens, in addition to bacterial and fungal species isolates

MeSH Terms

Conditions

CandidemiaTorulopsisSepsis

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Pappas, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2012

First Posted

February 2, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

June 9, 2014

Record last verified: 2014-06

Locations

US(5)