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

NCT ID: NCT04225195

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-06-30

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.

Conditions

Invasive Candidiasis; Invasive Aspergillosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

ABCD

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

mingui wang

Role: PRINCIPAL_INVESTIGATOR

Huashan Hospital affiliated to Fudan University ,Shanghai, China

Central Contacts

xiugao yang

Role: CONTACT

yangxiugao@mail.ecspc.com

86-021-60677906

Other Identifiers

CSPC/ LXMSB201901/PRO-III/A

Identifier Type: -

Identifier Source: org_study_id