An open, multicenter clinical study to evaluate the safety, efficacy, and population pharmacokinetics of Amphotericin B cholesteryl sulfate complex for invasive candidiasis and invasive aspergillosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000028942

Enrollment

Unknown

Registered

2020-01-08

Start date

2020-03-02

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive candidiasis and Invasive aspergillosis

Interventions

Experimental:Amphotericin B cholesteryl sulfate complex

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, regardless of gender; 2. Patients with confirmedinvasive candidiasisor or confirmed/probable/possibleinvasive aspergillosis; 3. Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication; 4. 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. 5. Signed Informed Consent Form.

Exclusion criteria

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 with abnormal liver function; 8. Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis; 9. Hypokalemia, which cannot be corrected before trial treatment; 10. Expected survival time is less than 2 months; 11. Patients with cardiac function of NYHA class III/IV; 12. Positive for HIV antibody; 13. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
alanine aminotransferase;Blood potassium;Blood culture;Urea nitrogen;	—

Countries

China

Contacts

Public ContactCejun Zhong

West China Hospital of Sichuan University

360079143@qq.com+86 13880733479

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026