Overview

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

Status:
Not yet recruiting
Trial end date:
2022-06-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open, multicenter clinical trial of ABCD for invasive candidiasis and invasive aspergillosis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Treatments:
Amphotericin B
Cholesteryl sulfate
Liposomal amphotericin B
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;