Study of the Clinical Benefits of Different Formulations of Amphotericin B

Active, not recruiting

• Conditions: Efficacy; Safety

• Registration Number: NCT06123832
• Lead Sponsor: Qianfoshan Hospital

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Primary Completion: 2024-08-31
• Last Update Submitted: 2024-10-15
• Last Update Posted: 2024-10-17
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Adverse Reaction Rate	Through study completion,up to half a year.	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.
Pathogen clearance rate	Through study completion,up to half a year.	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.

Trial Locations

Locations (1)

Rui Yang,MD; 🇨🇳 Jinan, Shandong, China