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

NCT04225195 | Unknown Phase 2

• 1 other identifier: CSPC/ LXMSB201901/PRO-III/A
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Invasive Candidiasis; Invasive Aspergillosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Overall response success rate at the end of ABCD treatment, Per Protocol Set(PPS) analysis set.

  4-6 weeks

• 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 days after starting treatment

Study Arms (1)

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

EXPERIMENTAL

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)

Interventions

Amphotericin B cholesteryl sulfate complex for injection(ABCD) 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.

Also known as: ABCD

Amphotericin B cholesteryl sulfate complex for injection(ABCD)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed invasive candidiasis or confirmed/probable/possible invasive aspergillosis;
• Agree to use contraceptive measures from the date of signing the informed consent to 6 weeks after the end of the last medication;
• 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.
• Signed Informed Consent Form.

You may not qualify if:

• Allergic to ABCD or azole antifungal drugs；
• 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;
• 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;
• Patients with Candida endocarditis, osteomyelitis, arthritis, endophthalmitis, abscess of liver and/or spleen, suppurative thrombophlebitis, or central nervous system infection;
• Patients with a history of drug abuse or drug dependence;
• Chronic pulmonary aspergillosis (duration ≥ 3 months), aspergilloma or allergic bronchopulmonary aspergillosis;
• Patients are known to have mixed invasive Candida or Aspergillus infections and/or ABCD is known to be ineffective;
• Patients with abnormal liver function;
• Patients with reduced renal function who require or are currently undergoing hemodialysis or peritoneal dialysis;
• Hypokalemia, which cannot be corrected before trial treatment;
• Expected survival time is less than 2 months;
• Patients with cardiac function of New York Heart Association（NYHA）class III/IV;
• Positive for HIV antibody;
• Pregnant or lactating women;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Conditions

Candidiasis, Invasive

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• mingui wang

  Huashan Hospital affiliated to Fudan University ,Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiugao yang

CONTACT

86-021-60677906; yangxiugao@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: January 13, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 13, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share