Antigenic and Antibody Detection of Candida

NCT ID: NCT03766932

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood culture candida positive group

No interventions assigned to this group

Tracheal aspiration candida culture positive group

No interventions assigned to this group

Urine candida culture positive group

No interventions assigned to this group

Other aseptic humoral candida positive group

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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wang kaifei

xie lixin

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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kaifei wang, doctor

Role: CONTACT

15001028681

Facility Contacts

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lixin xie, doctor

Role: primary

Other Identifiers

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Rapid diagnosis

Identifier Type: -

Identifier Source: org_study_id

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