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Status unknownNCT03766932Updated Dec 6, 2018

Antigenic and Antibody Detection of Candida

An observational study in To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-06.

Sponsored by Chinese PLA General Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 85 Years
Sex
All
01

Study 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.
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Conditions studied

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

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03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's planned enrollment of 500 is above the median of 123 across 63 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients with positive aseptic humoral culture among hospitalized patients.The control group were volunteers for outpatient or physical examination

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 -

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Groups and cohorts

  • Blood culture candida positive group
  • Tracheal aspiration candida culture positive group
  • Urine candida culture positive group
  • Other aseptic humoral candida positive group
06

What researchers measure

Primary outcomes

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

    ELISA was used to detect the samples

    Time frame: 1-2 years

07

Study locations

1 of 1 sites recruiting
  • Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
    Beijing, Beijing 100853, China
    • lixin xie, doctor · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03766932
Lead sponsor
Chinese PLA General Hospital
Responsible party
wang kaifei (xie lixin, Chinese PLA General Hospital) — Principal investigator
First posted
Dec 6, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Dec 6, 2018

Study contacts

kaifei wang, doctor
Contact
wangkaifei@126.com
15001028681

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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