Efficacy and Safety of Amphotericin B and Azoles in the Treatment of Invasive Fungal Disease
A Retrospective Clinical Study on the Efficacy and Safety of Amphotericin B Compared With Azoles in the Treatment of Invasive Fungal Disease
1 other identifier
observational
1,000
1 country
1
Brief Summary
Efficacy and safety of amphotericin B and azoles in the treatment of invasive fungal disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFirst Submitted
Initial submission to the registry
February 4, 2025
CompletedFirst Posted
Study publicly available on registry
February 11, 2025
CompletedFebruary 11, 2025
February 1, 2025
3.8 years
February 4, 2025
February 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical success rate
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 Outcomes (1)
Safety of amphotericin B and azoles
During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment
Study Arms (2)
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
Eligibility Criteria
Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
lingai PP Pan, PhD
Sichuan Provincial People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Chief Physician
Study Record Dates
First Submitted
February 4, 2025
First Posted
February 11, 2025
Study Start
May 1, 2021
Primary Completion
February 1, 2025
Study Completion
February 1, 2025
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share