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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03766932
Other study ID # Rapid diagnosis
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information

Verified date December 2018
Source Chinese PLA General Hospital
Contact kaifei wang, doctor
Phone 15001028681
Email wangkaifei@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2020
Est. primary completion date December 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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 -

Study Design


Related Conditions & MeSH terms

  • Candidiasis
  • To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection

Locations

Country Name City State
China Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Serum specific IgG, IgM and Mn levels in the enrolled population ELISA was used to detect the samples 1-2 years