Antigenic and Antibody Detection of Candida

Overview

In this study, a multicenter, prospective, synchronous blind, and controlled study was adopted to set the cut-off values of candida specific IgG, IgM, and Mn with the blood culture results as the gold standard, so as to evaluate the diagnostic value of candida specific IgG, IgM, and Mn levels in candida infection. 1. the cut-off values of serum specific IgG, IgM and Mn of candida sinensis infected population in China were established by comparing the positive results of blood culture of 300 healthy people and 100 patients with positive candida sinensis blood culture as the gold standard and using ROC curve (ROC curve). 2. 100 patients with positive tracheal aspiration culture and 100 patients with positive urine culture were enrolled. Serum levels of candida specific IgG, IgM and Mn were detected, and sensitivity, specificity, positive predictive value, negative predictive value and likelihood ratio of candida specific IgG, IgM and Mn in tracheal aspiration and urine were evaluated. 3. 200 high risk patients with candida infection were enrolled, and the aseptic fluid culture and the simultaneous detection of serum specific IgG, IgM and Mn were adopted to explore the diagnostic value of the detection method. 4. positive candida culture in sputum and positive candida culture in tracheal aspirate were taken as the control group to compare the levels of IgG, IgM and Mn in serum of the two groups, and to explore the diagnostic value of different sampling methods for candida pulmonary infection.

Full Title of Study: “Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2018

Arms, Groups and Cohorts

  • Blood culture candida positive group
  • Tracheal aspiration candida culture positive group
  • Urine candida culture positive group
  • Other aseptic humoral candida positive group

Clinical Trial Outcome Measures

Primary Measures

  • Serum specific IgG, IgM and Mn levels in the enrolled population
    • Time Frame: 1-2 years
    • ELISA was used to detect the samples

Participating in This Clinical Trial

Inclusion Criteria

Age: (1) 18-85 years old; (2) Candida positive in aseptic humoral culture - Exclusion Criteria:

(1) no informed consent has been signed; (2) patients with severe immune deficiency -

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chinese PLA General Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: wang kaifei, xie lixin – Chinese PLA General Hospital
  • Overall Contact(s)
    • kaifei wang, doctor, 15001028681, wangkaifei@126.com

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