Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT03766932
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.
Study:
NCT03766932
Study Brief:
Protocol Section:
NCT03766932