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Clinical Trials/NCT03766932
NCT03766932
Unknown
Not Applicable

Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital

Chinese PLA General Hospital1 site in 1 country500 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection
Sponsor
Chinese PLA General Hospital
Enrollment
500
Locations
1
Primary Endpoint
Serum specific IgG, IgM and Mn levels in the enrolled population
Last Updated
7 years ago

Overview

Brief Summary

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.
Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
December 31, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese PLA General Hospital
Responsible Party
Principal Investigator
Principal Investigator

wang kaifei

xie lixin

Chinese PLA General Hospital

Eligibility Criteria

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 -

Outcomes

Primary Outcomes

Serum specific IgG, IgM and Mn levels in the enrolled population

Time Frame: 1-2 years

ELISA was used to detect the samples

Study Sites (1)

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