This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.
This study will evaluate the safety, efficacy and population pharmacokinetic characteristics of ABCD in the treatment of invasive candidiasis and invasive aspergillosis. About 60 patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
IC patients will only receive intravenous treatment with ABCD, with the longest course of treatment up to 42 days. ABCD will be administered once a day at a dose of 3-4 mg/kg. Visit plan: screening period (D-4 to D-1), baseline period (D1), treatment period and follow-up period (14±3days after the end of the last dose of ABCD). IA patients will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. The total course of treatment should be at least 6 to 12 weeks. ABCD dosing regimen will be the same as that for IC patients. Visiting plan: screening period (D-4to D-1), baseline period (D1), treatment period and follow-up period.
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Time frame: 4-6 weeks
Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set
Overall response success rate at the end of ABCD treatment, m ITT analysis set
Time frame: 4-6 weeks
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Time frame: 4-6 weeks
Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.
Overall response success rate at the end of ABCD treatment, PPS analysis set.
Time frame: 4-6 weeks
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
Time frame: 4-6 weeks
30-d all-cause mortality rate after starting treatment; mITT analysis set
30-d all-cause mortality rate after starting treatment; mITT analysis set
Time frame: 30 days after starting treatment
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