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NCT Number: NCT06819410

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

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

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Key information

Conditions

Invasive Fungal Disease Bacterial Infections and Mycoses Infections Invasive Fungal Infections Mycoses

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location status: Recruiting

Location contact

lingai Pan, PhD

CONTACT

[email protected]

17708130236

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

lingai Pan, PhD

CONTACT

[email protected]

17708130236

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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