Study of the Clinical Benefits of Different Formulations of Amphotericin B

NCT ID: NCT06123832

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 184 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Efficacy; Safety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Experimental Group

Liposomal Amphotericin B for Injection (Ampicillin®)

No interventions assigned to this group

Control Group

Liposome of Amphotericin B for Injection (Fungoxone®), Cholesteryl Sulfate Complex of Amphotericin B for Injection (Amphotericin®), Amphotericin B for Injection

No interventions assigned to this group

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rui Yang

Associate professor of pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Yang, MD

Role: PRINCIPAL_INVESTIGATOR

Qianfoshan Hospital

Locations

Rui Yang,MD

Jinan, Shandong, China

Countries

China

Other Identifiers

LCYX-YR-20230102

Identifier Type: -

Identifier Source: org_study_id