Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel

Cornelius J. Clancy, Peter G. Pappas, Jose Antonio Vazquez, Marc A. Judson, Dimitrios P. Kontoyiannis, George R. Thompson, Kevin W. Garey, Annette Reboli, Richard N. Greenberg, Senu Apewokin, G. Marshall Lyon, Luis Ostrosky-Zeichner, Alan H.B. Wu, Ellis Tobin, M. Hong Nguyen, Angela M. Caliendo

Research output: Contribution to journalArticle

32 Citations (Scopus)

Abstract

Background Blood cultures are approximately 50% sensitive for diagnosing invasive candidiasis. The T2Candida nanodiagnostic panel uses T2 magnetic resonance and a dedicated instrument to detect Candida directly within whole blood samples. Methods Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida and companion cultures (cBCs). T2Candida results are reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC. Results Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4-148.4). T2Candida and cBCs were positive in 45% (69/152) and 24% (36/152) of patients, respectively (P <.0001). T2Candida clinical sensitivity was 89%, as positive results were obtained in 32/36 patients with positive cBCs. Combined test results were both positive (T2+/cBC+), 21% (32/152); T2+/cBC-, 24% (37/152); T2-/cBC+, 3% (4/152); and T2-/cBC, 52% (79/152). Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity and T2+/cBC- results (P values <.05). Conclusions T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. Clinical Trials Registration NCT01525095.

Original languageEnglish (US)
Pages (from-to)1678-1686
Number of pages9
JournalClinical Infectious Diseases
Volume66
Issue number11
DOIs
StatePublished - May 17 2018

Fingerprint

Candidemia
Multicenter Studies
Candida
Prospective Studies
Candida albicans
Candida tropicalis
Candida glabrata
Infection
Invasive Candidiasis
Neutropenia
Magnetic Resonance Spectroscopy
Therapeutics
Clinical Trials
Blood Culture

Keywords

  • T2 magnetic resonance
  • T2Candida
  • candidemia
  • candidiasis
  • diagnosis

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2) : A Prospective, Multicenter Study of the T2Candida Panel. / Clancy, Cornelius J.; Pappas, Peter G.; Vazquez, Jose Antonio; Judson, Marc A.; Kontoyiannis, Dimitrios P.; Thompson, George R.; Garey, Kevin W.; Reboli, Annette; Greenberg, Richard N.; Apewokin, Senu; Lyon, G. Marshall; Ostrosky-Zeichner, Luis; Wu, Alan H.B.; Tobin, Ellis; Nguyen, M. Hong; Caliendo, Angela M.

In: Clinical Infectious Diseases, Vol. 66, No. 11, 17.05.2018, p. 1678-1686.

Research output: Contribution to journalArticle

Clancy, CJ, Pappas, PG, Vazquez, JA, Judson, MA, Kontoyiannis, DP, Thompson, GR, Garey, KW, Reboli, A, Greenberg, RN, Apewokin, S, Lyon, GM, Ostrosky-Zeichner, L, Wu, AHB, Tobin, E, Nguyen, MH & Caliendo, AM 2018, 'Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel', Clinical Infectious Diseases, vol. 66, no. 11, pp. 1678-1686. https://doi.org/10.1093/cid/cix1095
Clancy, Cornelius J. ; Pappas, Peter G. ; Vazquez, Jose Antonio ; Judson, Marc A. ; Kontoyiannis, Dimitrios P. ; Thompson, George R. ; Garey, Kevin W. ; Reboli, Annette ; Greenberg, Richard N. ; Apewokin, Senu ; Lyon, G. Marshall ; Ostrosky-Zeichner, Luis ; Wu, Alan H.B. ; Tobin, Ellis ; Nguyen, M. Hong ; Caliendo, Angela M. / Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2) : A Prospective, Multicenter Study of the T2Candida Panel. In: Clinical Infectious Diseases. 2018 ; Vol. 66, No. 11. pp. 1678-1686.
@article{61a420e19bf648379a1ba7987918ac4d,
title = "Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel",
abstract = "Background Blood cultures are approximately 50{\%} sensitive for diagnosing invasive candidiasis. The T2Candida nanodiagnostic panel uses T2 magnetic resonance and a dedicated instrument to detect Candida directly within whole blood samples. Methods Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida and companion cultures (cBCs). T2Candida results are reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC. Results Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4-148.4). T2Candida and cBCs were positive in 45{\%} (69/152) and 24{\%} (36/152) of patients, respectively (P <.0001). T2Candida clinical sensitivity was 89{\%}, as positive results were obtained in 32/36 patients with positive cBCs. Combined test results were both positive (T2+/cBC+), 21{\%} (32/152); T2+/cBC-, 24{\%} (37/152); T2-/cBC+, 3{\%} (4/152); and T2-/cBC, 52{\%} (79/152). Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity and T2+/cBC- results (P values <.05). Conclusions T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. Clinical Trials Registration NCT01525095.",
keywords = "T2 magnetic resonance, T2Candida, candidemia, candidiasis, diagnosis",
author = "Clancy, {Cornelius J.} and Pappas, {Peter G.} and Vazquez, {Jose Antonio} and Judson, {Marc A.} and Kontoyiannis, {Dimitrios P.} and Thompson, {George R.} and Garey, {Kevin W.} and Annette Reboli and Greenberg, {Richard N.} and Senu Apewokin and Lyon, {G. Marshall} and Luis Ostrosky-Zeichner and Wu, {Alan H.B.} and Ellis Tobin and Nguyen, {M. Hong} and Caliendo, {Angela M.}",
year = "2018",
month = "5",
day = "17",
doi = "10.1093/cid/cix1095",
language = "English (US)",
volume = "66",
pages = "1678--1686",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "11",

}

TY - JOUR

T1 - Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2)

T2 - A Prospective, Multicenter Study of the T2Candida Panel

AU - Clancy, Cornelius J.

AU - Pappas, Peter G.

AU - Vazquez, Jose Antonio

AU - Judson, Marc A.

AU - Kontoyiannis, Dimitrios P.

AU - Thompson, George R.

AU - Garey, Kevin W.

AU - Reboli, Annette

AU - Greenberg, Richard N.

AU - Apewokin, Senu

AU - Lyon, G. Marshall

AU - Ostrosky-Zeichner, Luis

AU - Wu, Alan H.B.

AU - Tobin, Ellis

AU - Nguyen, M. Hong

AU - Caliendo, Angela M.

PY - 2018/5/17

Y1 - 2018/5/17

N2 - Background Blood cultures are approximately 50% sensitive for diagnosing invasive candidiasis. The T2Candida nanodiagnostic panel uses T2 magnetic resonance and a dedicated instrument to detect Candida directly within whole blood samples. Methods Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida and companion cultures (cBCs). T2Candida results are reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC. Results Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4-148.4). T2Candida and cBCs were positive in 45% (69/152) and 24% (36/152) of patients, respectively (P <.0001). T2Candida clinical sensitivity was 89%, as positive results were obtained in 32/36 patients with positive cBCs. Combined test results were both positive (T2+/cBC+), 21% (32/152); T2+/cBC-, 24% (37/152); T2-/cBC+, 3% (4/152); and T2-/cBC, 52% (79/152). Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity and T2+/cBC- results (P values <.05). Conclusions T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. Clinical Trials Registration NCT01525095.

AB - Background Blood cultures are approximately 50% sensitive for diagnosing invasive candidiasis. The T2Candida nanodiagnostic panel uses T2 magnetic resonance and a dedicated instrument to detect Candida directly within whole blood samples. Methods Patients with Candida albicans, Candida glabrata, Candida parapsilosis, Candida tropicalis, or Candida krusei candidemia were identified at 14 centers using diagnostic blood cultures (dBCs). Follow-up blood samples were collected concurrently for testing by T2Candida and companion cultures (cBCs). T2Candida results are reported qualitatively for C. albicans/C. tropicalis, C. glabrata/C. krusei, and C. parapsilosis. T2Candida and cBCs were positive if they detected a species present in the dBC. Results Median time between collection of dBC and T2Candida/cBC samples in 152 patients was 55.5 hours (range, 16.4-148.4). T2Candida and cBCs were positive in 45% (69/152) and 24% (36/152) of patients, respectively (P <.0001). T2Candida clinical sensitivity was 89%, as positive results were obtained in 32/36 patients with positive cBCs. Combined test results were both positive (T2+/cBC+), 21% (32/152); T2+/cBC-, 24% (37/152); T2-/cBC+, 3% (4/152); and T2-/cBC, 52% (79/152). Prior antifungal therapy, neutropenia, and C. albicans candidemia were independently associated with T2Candida positivity and T2+/cBC- results (P values <.05). Conclusions T2Candida was sensitive for diagnosing candidemia at the time of positive blood cultures. In patients receiving antifungal therapy, T2Candida identified bloodstream infections that were missed by cBCs. T2Candida may improve care by shortening times to Candida detection and species identification compared to blood cultures, retaining sensitivity during antifungal therapy and rendering active candidemia unlikely if results are negative. Clinical Trials Registration NCT01525095.

KW - T2 magnetic resonance

KW - T2Candida

KW - candidemia

KW - candidiasis

KW - diagnosis

UR - http://www.scopus.com/inward/record.url?scp=85046286688&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85046286688&partnerID=8YFLogxK

U2 - 10.1093/cid/cix1095

DO - 10.1093/cid/cix1095

M3 - Article

AN - SCOPUS:85046286688

VL - 66

SP - 1678

EP - 1686

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 11

ER -