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

An Open, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Population Pharmacokinetics of ABCD for Invasive Candidiasis and Invasive Aspergillosis

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

Study Overview

• Status: Unknown
• Conditions: Invasive Aspergillosis; Invasive Candidiasis
• Intervention / Treatment: Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD); 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.; Other Names: ABCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: mingui wang, Huashan Hospital affiliated to Fudan University ,Shanghai, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): April 1, 2022
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: January 3, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (ACTUAL): January 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 8, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Candidiasis; Candidiasis, Invasive; Aspergillosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Protease Inhibitors; Protective Agents; Anti-Bacterial Agents; Antifungal Agents; Serine Proteinase Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anticarcinogenic Agents; Amebicides; Amphotericin B; Liposomal amphotericin B; Cholesteryl sulfate
• Other Study ID Numbers: CSPC/ LXMSB201901/PRO-III/A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No