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

CSPC Pharmaceutical Group

Status and phase: Unknown; Phase 2

Conditions: Invasive Aspergillosis; Invasive Candidiasis

Treatments: Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04225195

CSPC/ LXMSB201901/PRO-III/A

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Experimental group

Description:

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.

Treatment:

Drug: Amphotericin B cholesteryl sulfate complex for injection(ABCD)