Invasive Pulmonary Aspergillosis
Conditions
Interventions
Experimental group:Voriconazole 6 mg/kg for the first dose, 2 mg/kg for the second dose after 12 hours), and maintenance dose (after the third dose) 2 mg/kg after 12 hours
Control group:Voriconazole 6 mg/kg for the first dose, 6 mg/kg for the second dose after 12 hours), and maintenance dose (after the third dose) 2 mg/kg after 12 hours
Sponsors
The Third Affliated Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients agree to participate in this study and sign the informed consent; 2. No gender restriction, aged 18-65 years; 3. ''Acute-on-chronic liver failure'' follows the diagnostic criteria of the 2018 Chinese Guidelines for the Diagnosis and Treatment of Liver Failure: (1) Extreme fatigue, and severe gastrointestinal symptoms such as obvious anorexia, abdominal distension, nausea, and vomiting; (2) Progressive deepening of jaundice in the short term (serum total bilirubin is greater than or equal to 10 times the upper limit of normal or the daily increase is greater than or equal to 17 µmol/L); (3) The bleeding tendency is obvious, the prothrombin activity (PTA) is less than or equal to 40%, and other reasons are excluded; (4) Complications such as infection, hepatic encephalopathy, ascites, hepatorenal syndrome, electrolyte disturbance, etc. may be complicated; 4. ''Invasive pulmonary aspergillosis'' follows the IPA diagnostic criteria in the 2008 edition of the European Organization for Research and Treatment of Cancer/Mycoses Study Group: Practice Guidelines for the Diagnosis and Management of Invasive Fungal Infections (including confirmed Proven and suspected Probable cases): (1) Diagnosis of Proven: positive for Aspergillus culture in lung histopathology or bronchoalveolar lavage fluid obtained through bronchoscopy; (2) Probable diagnosis: host factors + clinical criteria (symptoms such as fever, cough, expectoration, signs such as pulmonary rales, lung imaging findings supporting Aspergillus infection) + microbiological criteria (Histopathology shows hyphae highly consistent with Aspergillus, but culture is negative; or GM test positive and G test positive).
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating patients; 2. Acute fatty liver of pregnancy; 3. Patients with HIV infection; 4. Accompanied by serious underlying diseases, including uncontrolled clinically significant heart, lung, kidney, digestive, neurological, psychiatric, immunological, metabolic or malignant tumors; 5. Those who were allergic to voriconazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| antifungal effect;Voriconazole plasma concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| CT lung imaging;infection inflammatory markers;hepatic and renal function;coagulation function;mortality;adverse event incidence; | — |
Countries
China
Contacts
Public ContactLiu Jing
The Third Affliated Hospital of Sun Yat-Sen University
Outcome results
None listed