Efficacy and Safety of Amphotericin B and Azoles in the Treatment of Invasive Fungal Disease

February 10, 2025 updated by: Lingai Pan, Sichuan Provincial People's Hospital

A Retrospective Clinical Study on the Efficacy and Safety of Amphotericin B Compared With Azoles in the Treatment of Invasive Fungal Disease

Efficacy and safety of amphotericin B and azoles in the treatment of invasive fungal disease

Study Overview

Status

Recruiting

Conditions

Detailed Description

The medical records, demographic characteristics and clinical data of patients with invasive fungal disease treated with amphotericin B or azoles were collected through the electronic medical record system of Sichuan Provincial People's Hospital from 2021 to 2024. To evaluate the efficacy and safety of these two types of drugs.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.

Description

Inclusion Criteria:

  • There is no age limit, gender is not limited
  • Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.

Exclusion Criteria:

  • Patients with incomplete data or other factors affecting the clinical outcome judgement
  • Patients who are judged by the investigator to be unsuitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Treatment with polyene antifungal drugs
The dosage and course of Amphotericin B or Amphotericin B cholesteryl sulphate complex were determined by clinicians, and this study was registered according to clinical practice
Treatment with azole antifungal drugs
The dosage and course of triazoles or imidazole antifungal drugs were determined by clinicians, and this study was registered according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical success rate
Time Frame: The end of treatment, up to 1 year
Clinical success incudes cure or symptom improvement，which means patients are alive, IFD-related symptoms and signs, radiographic abnormalities improve or disappear completely, and microbiological evidence suggests fungal clearance. The proportion of patients with cured or improved symptoms in the total population was analyzed.
The end of treatment, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of amphotericin B and azoles
Time Frame: During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment
Safety evaluation was mainly based on the incidence of adverse events / adverse reactions in the two groups of patients.
During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Study Chair: lingai PP Pan, PhD, Sichuan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lunshen(Research)No.818,2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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