Amphotericin B Cholesteryl Sulfate Complex for Injection(ABCD) in the Treatment of Invasive Candidiasis and Invasive Aspergillosis

Phase 2

• Conditions: Invasive Candidiasis; Invasive Aspergillosis
• Interventions: Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)

• Registration Number: NCT04225195
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary

This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.

Detailed Description

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 Timeline

• Status Verified: 2019-12
• Study Start: 2020-01
• Study First Submitted: 2020-01-03
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13
• Primary Completion: 2022-04
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
2. Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
3. Female subjects must meet one of the following conditions: surgical sterilization;menopause for at least 1 year;a negative result of serum/urine pregnancy test before enrollment.
4. Signed Informed Consent Form.

Exclusion Criteria

1. Allergic to ABCD or azole antifungal drugs；
2. For IC patients, administration of more than 48 hours of systemic antifungal treatment within 96 hours before enrollment; or 1 dose of amphotericin B in 7 days;
3. For IA patients, administration of more than 96 hours of systemic antifungal therapy for this infection before enrollment, or 1 dose of amphotericin B in 7 days;
4. Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
5. Patients with a history of drug abuse or drug dependence;
6. Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
7. Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
8. Patients with abnormal liver function;
9. Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
10. Hypokalemia, which cannot be corrected before trial treatment;
11. Expected survival time is less than 2 months;
12. Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
13. Positive for HIV antibody;
14. Pregnant or lactating women;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amphotericin B cholesteryl sulfate complex for injection(ABCD)	Amphotericin B cholesteryl sulfate complex for injection(ABCD)	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.

Primary Outcome Measures

Name	Time	Method
Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, Intent-to-Treat (ITT) analysis set	4-6 weeks	Number of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set
Overall response success rate at the end of ABCD treatment, modified ITT (mITT) analysis set	4-6 weeks	Overall response success rate at the end of ABCD treatment, m 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	Proportion of patients who discontinued treatment due to study drug-related adverse events or abnormal laboratory tests, ITT analysis set

Secondary Outcome Measures

Name	Time	Method
Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.	4-6 weeks	Overall response success rate at the end of ABCD treatment, PPS analysis set.
The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set	4-6 weeks	The proportion of patients with microbiologically effective outcome at the end of treatment, micro-mITT analysis set
30-d all-cause mortality rate after starting treatment; mITT analysis set	30 days after starting treatment	30-d all-cause mortality rate after starting treatment; mITT analysis set