Chronic pulmonary aspergillosis
Conditions
Interventions
experimental group:Inhalation of 10 mL amphotericin B solution was completed in no less than 15~20 minutes
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria will be eligible for this study: (1) Age=18,no gender limitation. (2) Chronic symptoms of the system or lungs, such as cough, expectoration, hemoptysis, fever, dyspnea, weight loss,etc., more than 3 months; (3) According to the diagnostic criteria of chronic Pulmonary aspergillosis: Theoretical Basis and Clinical Diagnosis and Treatment Guidelines jointly issued by the European Society of Clinical Microbiology and Infectious Diseases/European Respiratory Society (ESCMID/ERS) in 2016, the following four conditions were met: a. Imaging findings showed one or more cavities, with or without fungal ball formation. B. Direct evidence of aspergillus infection (positive pathological microscopic examination or culture) or positive immunological reaction of Aspergillus; C. Lasts for at least 3 months. (4) All subjects agreed to contraception from signing the informed consent form until 6 weeks after the end of the last medication. 1) Women must meet one of the following conditions: a. Postmenopausal women who have been without menstruation for at least 1 year; B. Fertile, the following conditions should be met: negative results of serum/urine pregnancy test before enrollment in this study; Throughout the study period, agreed to use a method of birth control that was recognized as highly effective. 2) The male subject or his partner agreed to use an approved highly effective contraceptive throughout the study period. (5) The subject and/or his/her legal representative fully understand the content of the test and are willing to participate in the test and sign the informed consent in person.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be included in this study: (1) Non-CPA, such as acute invasive pulmonary aspergillosis, allergic bronchopulmonary aspergillosis (ABPA); (2) active tuberculosis; (3) Uncontrolled hemoptysis (hemoptysis exceeds 50ml per day) (4) Chronic pulmonary aspergillus disease caused by amphotericin B insensitive or drug resistant aspergillus, such as Aspergillus terraeus, Aspergillus stellatus, etc.; (5) Abnormal liver function [ASpartate aminotransferase (AST) or alanine aminotransferase (ALT) =5 times the upper limit of normal value,or ALT or AST=3 times the upper limit of normal value with total bilirubin =1.5 times the upper limit of normal value]; (6) patients with renal dysfunction or who are currently undergoing hemodialysis or peritoneal dialysis; (7) Clinically significant hypokalemia (defined as serum potassium concentration < 3.2 mmol/L, or lower than the lower limit of normal in patients undergoing digitalis), and hypokalemia cannot be corrected before initiation of trial therapy; (8) HIV-positive persons; (9) pregnant and lactating women; (10) people with a history of drug abuse (non-medical use of narcotic drugs or psychotropic substances) and drug dependence (sedative-hypnotic drugs, analgesics, narcotics, stimulants and psychotropic drugs, etc.); (11) allergic to amphotericin B or its adjuvant or solvent; (12) The expected survival time is less than 3 months; (13) The patient had participated in this study; Conditions considered unsuitable for participation in the study by the investigator, such as concomitancy of severe organ insufficiency or clinically significant laboratory abnormalities, understanding or compliance problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| imaging; | — |
Countries
CHINA
Contacts
Public ContactFeng Ye
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed