Study of the Clinical Benefits of Different Formulations of Amphotericin B
Study Details
Study Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients discharged from January 1, 2020 to the present;
-
Patients with a record of amphotericin B use.
Exclusion Criteria:
1.Key information missing from patient studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rui Yang,MD | Jinan | Shandong | China |
Sponsors and Collaborators
- Qianfoshan Hospital
Investigators
- Principal Investigator: Rui Yang, MD, Qianfoshan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCYX-YR-20230102