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

NCT04225195 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-13

No results posted yet for this study

Summary

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

Conditions

  • Invasive Candidiasis
  • Invasive Aspergillosis

Interventions

DRUG

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.

Sponsors & Collaborators

  • CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • mingui wang · Huashan Hospital affiliated to Fudan University ,Shanghai, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2022-04-30
Completion
2022-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225195 on ClinicalTrials.gov