Invasive Fungal Disease
Conditions
Interventions
The control group:The control group received intravenous voriconazole as the antifungal treatment.
The treatment course will be administered for a minimum of 14 days, with the decision to continue stu
The experimental group:The experimental group was administered intravenous amphotericin B cholesteryl sulfate complex for injection for antifungal therapy.
The treatment course will be administered fo
Sponsors
The Affiliated Hospital of Medical College Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Signed informed consent form (or by legal authorized representative for patients unable to sign) with commitment to comply with study procedures and complete the full course of the study. 2.Aged >=18 and . 4.Time interval between enrollment and initiation of intervention therapy should not exceed 24 hours.
Exclusion criteria
Exclusion criteria: 1.Inability to obtain informed consent from the subject, family member, or authorized representative. 2.Known hypersensitivity to voriconazole, amphotericin B, or any component of the cholesteryl sulfate complex. 3.Current or planned use of CYP3A4 substrates (including terfenadine, astemizole, cisapride, pimozide, quinidine, and ivabradine), sirolimus, rifampicin, carbamazepine, phenobarbital, efavirenz (standard dose of 400 mg once daily or higher), ritonavir (high dose, >=400 mg twice daily), or ergot alkaloids (including ergotamine and dihydroergotamine). 4.Hepatic dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=5 times the upper limit of normal (ULN), or ALT/AST >3 times ULN with total bilirubin >1.5 times ULN. 5.Renal impairment requiring or currently undergoing hemodialysis or peritoneal dialysis. 6.Clinically significant hypokalemia (defined as serum potassium <3.2 mmol/L, or below the lower limit of normal in patients receiving digitalis therapy) that cannot be corrected prior to initiation of trial treatment. 7.Expected survival time <3 months. 8.Pregnant or lactating women, or women of childbearing potential not using adequate contraception. 9.Any other condition that, in the investigator's judgment, would make the patient unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic response rate;Length of stay in the ICU;SOFA and APACHE II scores;90-day all-cause mortality;Pharmacokinetic characteristics of the ABCD group; | — |
Countries
China
Contacts
Public ContactXing Jinyan
The Affiliated Hospital of Medical College Qingdao University
Outcome results
None listed