Study of the Clinical Benefits of Different Formulations of Amphotericin B

NCT06123832 | Unknown

• 1 other identifier: LCYX-YR-20230102
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Efficacy; Safety

Keywords

Liposomal Amphotericin B for Injection; Amphotericin B Cholesteryl Sulfate Complex for Injection; Amphotericin B for Injection; Safety; Efficacy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Key information missing from patient studies.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Rui Yang,MD

Jinan, Shandong, China

Location

Study Officials

• Rui Yang, MD

  Qianfoshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of pharmacy

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: September 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 17, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)