Study of the Clinical Benefits of Different Formulations of Amphotericin B

Safety Clinical Trial

Official title:

Study of the Clinical Benefits of Different Formulations of Amphotericin B

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06123832
• Other study ID #: LCYX-YR-20230102
• Status: Active, not recruiting
• Start date: January 1, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 184
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Efficacy
• Safety

Locations

Country	Name	City	State
China	Rui Yang,MD	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.