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Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study

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ClinicalTrials.gov Identifier: NCT03027089
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : January 20, 2017
Sponsor:
Collaborators:
Navy General Hospital, Beijing
Air Force General Hospital of the PLA
307 Hospital of PLA
Information provided by (Responsible Party):
Lixin Xie, Chinese PLA General Hospital

Brief Summary:
Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)

Condition or disease
Chronic Pulmonary Aspergillosis

Detailed Description:

chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious diseases, and the incidence is increased rapidly in recent years. Serum detection of Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA, however, there is no formal report on the appropriate cut-off value for Aspergillus-specific IgG assay in Chinese patients. This study aimed to establish the datum.

Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is associated with the acute phase of an infection and IgA is associated with mucosal immunity. Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be detected simultaneously by the commercial available kits.

The investigators will establish the cut-off values of three antibodies by proven CPA patients and negative controls. Then, the cut-off values will be assessed in participants who have a suspected CPA, and the sensitivity, specificity, positive and negative predict value of the antibodies assays will be compared with that of standard diagnostic methods.

After performing the above diagnostic tests, CPA could be diagnosed more accurately and rapidly, so that the antifungal therapy could be evaluated more correctly and timely.


Study Type : Observational
Estimated Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis




Primary Outcome Measures :
  1. The levels of Aspergillus-specific IgG, IgM and IgA in sera and BALF from 560 patients with suspected CPA and 100 healthy blood donors were tested by ELISA assays [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All subjects were selected with lesions presented as cavity, nodule,mass or "destroyed lung" caused by fibrosis in CT imaging
Criteria

Inclusion Criteria:

18 years to 85 years Lesions presented as cavity, nodule,mass or "destroyed lung" caused by fibrosis in CT imaging

Exclusion Criteria:

  • seriously immunocompromised patients

    1. Recent history of neutropenia (<0.5 × 109neutrophils/L [<500 neutrophils/mm3] for>10 days) temporally related to the onset of fungal disease
    2. Receipt of an allogeneic stem cell transplant
    3. Prolonged use of corticosteroids (excluding among patients with allergic bronchopulmonary aspergillosis) at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for >3 weeks
    4. Treatment with other recognized T cell immunosuppressants, such as cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or nucleoside analogues during the past 90 days
    5. Inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency)
  • antifungal drug use within 3 months of screening
  • dropout
  • Pregnancy or lactation
  • no inform consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027089


Contacts
Contact: xiuqing ma, Doctor +8601066936184 mxq820812@163.com

Locations
China, Beijing
301 PLA general hospital Recruiting
BeiJing, Beijing, China, 100853
Contact: xiuqing ma, Doctor    +8601066936184      
Sponsors and Collaborators
Chinese PLA General Hospital
Navy General Hospital, Beijing
Air Force General Hospital of the PLA
307 Hospital of PLA

Publications of Results:
Responsible Party: Lixin Xie, professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03027089     History of Changes
Other Study ID Numbers: hr4987
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lixin Xie, Chinese PLA General Hospital:
Aspergillus-specific IgG

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases