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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amphotericin B cholesteryl sulfate complex for injection(ABCD) | Experimental | Patients with invasive candidiasis (IC) will only receive intravenous treatment with ABCD. ABCD will be administered once a day at a dose of 3-4 mg/kg. Patients with invasive aspergillosis (IA) will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. ABCD dosing regimen will be the same as that for IC patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amphotericin B cholesteryl sulfate complex for injection(ABCD) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 4-6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4-6 weeks |
| The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiugao yang | Contact | 86-021-60677906 | yangxiugao@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| mingui wang | Huashan Hospital affiliated to Fudan University ,Shanghai, China | Principal Investigator |
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The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set |
| 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 | 30 days after starting treatment |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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