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Antigenic and Antibody Detection of Candida

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03766932
Enrollment
500
Registered
2018-12-06
Start date
2018-01-01
Completion date
2020-12-31
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Sponsors

Chinese PLA General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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 -

Design outcomes

Primary

MeasureTime frameDescription
Serum specific IgG, IgM and Mn levels in the enrolled population1-2 yearsELISA was used to detect the samples

Countries

China

Contacts

Primary Contactkaifei wang, doctor
wangkaifei@126.com15001028681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026