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

NCT03027089 | Unknown DMC

• 1 other identifier: hr4987
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pulmonary Aspergillosis

Keywords

Aspergillus-specific IgG

Outcome Measures

Primary Outcomes (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

  2 years

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• seriously immunocompromised patients
• Recent history of neutropenia (\<0.5 × 109neutrophils/L \[\<500 neutrophils/mm3\] for\>10 days) temporally related to the onset of fungal disease
• Receipt of an allogeneic stem cell transplant
• 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
• 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
• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Navy General Hospital, Beijing: collaborator
• Air Force General Hospital of the PLA: collaborator
• 307 Hospital of PLA: collaborator

Study Sites (1)

301 PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 26699723 RESULT

• 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.

  PMID: 26680697 RESULT

• 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.

  PMID: 31387539 DERIVED

Central Study Contacts

xiuqing ma, Doctor

CONTACT

+8601066936184; mxq820812@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: January 20, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)