Study of the Clinical Benefits of Different Formulations of Amphotericin B

This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.

Study Overview

• Status: Active, not recruiting
• Conditions: Efficacy; Safety

Detailed Description

The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.

• Study Type: Observational
• Enrollment (Estimated): 184

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Rui Yang,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with documented amphotericin B use discharged from 5 tertiary care hospitals across the country from January 1, 2020 to the present were selected for the study to exclude patients with missing key information for the study and were divided into experimental and control groups for the study.

Description

Inclusion Criteria:

1. Patients discharged from January 1, 2020 to the present;
2. Patients with a record of amphotericin B use.

Exclusion Criteria:

1.Key information missing from patient studies.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Experimental Group; Liposomal Amphotericin B for Injection (Ampicillin®)
Control Group; Liposome of Amphotericin B for Injection (Fungoxone®), Cholesteryl Sulfate Complex of Amphotericin B for Injection (Amphotericin®), Amphotericin B for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Adverse Reaction Rate	The incidence of total adverse reactions was analyzed to assess the difference in safety of amphotericin B by formulation type in domestic clinical application, to provide real-world evidence for clinical drug selection, and to provide evidence-based evidence in support of rational clinical drug use.	Through study completion,up to half a year.
Pathogen clearance rate	To assess the differences in effectiveness of amphotericin B by formulation type in domestic clinical application by analyzing the pathogen clearance rate, to provide real-world evidence for clinical dosing selection, and to provide evidence-based evidence to support rational clinical dosing.	Through study completion,up to half a year.

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Rui Yang, MD, Qianfoshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): August 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: October 15, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Liposomal Amphotericin B for Injection; Amphotericin B Cholesteryl Sulfate Complex for Injection; Amphotericin B for Injection
• Other Study ID Numbers: LCYX-YR-20230102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No