Clinical trial NCT03027089: Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study
Official title: Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA) in Chinese Patients -Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pulmonary Aspergillosis
Keywords: Aspergillus-specific IgG
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Navy General Hospital, Beijing
name: Air Force General Hospital of the PLA
name: 307 Hospital of PLA
First posted: 2017-01-20
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: BeiJing
country: China
facility: 301 PLA general hospital
state: Beijing
Study officials:
References:
citation: Denning DW, Cadranel J, Beigelman-Aubry C, Ader F, Chakrabarti A, Blot S, Ullmann AJ, Dimopoulos G, Lange C; European Society for Clinical Microbiology and Infectious Diseases and European Respiratory Society. Chronic pulmonary aspergillosis: rationale and clinical guidelines for diagnosis and management. Eur Respir J. 2016 Jan;47(1):45-68. doi: 10.1183/13993003.00583-2015.
citation: Page ID, Richardson MD, Denning DW. Comparison of six Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA). J Infect. 2016 Feb;72(2):240-9. doi: 10.1016/j.jinf.2015.11.003. Epub 2015 Dec 8.
citation: Ma X, Wang K, Zhao X, Liu Y, Li Y, Yu X, Li C, Denning DW, Xie L. Prospective study of the serum Aspergillus-specific IgG, IgA and IgM assays for chronic pulmonary aspergillosis diagnosis. BMC Infect Dis. 2019 Aug 6;19(1):694. doi: 10.1186/s12879-019-4303-x.