To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida InfectionNCT03766932
Antigenic and Antibody Detection of Candida
An observational study of To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with positive aseptic humoral culture among hospitalized patients.The control group were volunteers for outpatient or physical examination
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 -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pulmonary and Critical Care Medicine, Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
lixin xie, doctor
About this study
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.
- 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).
- 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.
- 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.
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood culture candida positive group | Not described | |
| Tracheal aspiration candida culture positive group | Not described | |
| Urine candida culture positive group | Not described | |
| Other aseptic humoral candida positive group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum specific IgG, IgM and Mn levels in the enrolled population
ELISA was used to detect the samples
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida InfectionStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang kaifei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766932
- Sponsor's protocol ID
- Rapid diagnosis
- Status last verified
- Dec 2018
- First submitted
- 5 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Department of Pulmonary & Critical Care Medicine, Chinese PLA General Hospital
- ClinicalTrials.gov ID
- NCT03766932
- Acronym / sponsor ID
- Rapid diagnosis
- Conditions
- To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blood culture candida positive group | – | – |
| Tracheal aspiration candida culture positive group | – | – |
| Urine candida culture positive group | – | – |
| Other aseptic humoral candida positive group | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with positive aseptic humoral culture among hospitalized patients.The control group were volunteers for outpatient or physical examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum specific IgG, IgM and Mn levels in the enrolled population
Time frame: 1-2 years
ELISA was used to detect the samples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Evaluate the Diagnostic Value of Candida Antigen Antibody Detection for Candida Infection, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact kaifei wang, doctor (15001028681, wangkaifei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum specific IgG, IgM and Mn levels in the enrolled population (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.