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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06123832
Other study ID # LCYX-YR-20230102
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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