To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection Clinical Trial
Official title:
Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
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.
| 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 - |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese PLA General Hospital |
China,
| 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 |