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RecruitingNCT06819410Updated Feb 11, 2025

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

An observational study in Invasive Fungal Disease, sponsored by Sichuan Provincial People's Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-02-11.

Sponsored by Sichuan Provincial People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 6 months later.

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Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
1,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 29 studies in Invasive Fungal Infections with a site in China — 12 open to participants now, 12 under way, none of them phase 3. Invasive Fungal Infections · China.

Planned enrollment
3rd of 17
1,000 · median 120
Started
2021
with 2 others
Observational
17 of 29
10 open now
Primary completion
2025-02
later than 2 of 11 live
Registered
18th of 29
by date
Lead sponsor
2 of 29
Sichuan Provincial People's Hospital

Among the 29 studies in Invasive Fungal Infections with a site in China, this one is the 3rd largest by planned enrollment of the 17 observational ones that give a count, is one of 3 that started in 2021, is one of 17 observational ones, reaches primary completion later than 2 of the 11 other live ones, and was the 18th registered.

Invasive Fungal Infections

136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.

Browse Invasive Fungal Infections studies →

Open to participants now

12 of the 29 studies in Invasive Fungal Infections with a site in China are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 20 Invasive Fungal Infections studies recruiting now, 12 (60%) set no upper age limit and 5 (25%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.

This study: all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Invasive Fungal Disease
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: The end of treatment, up to 1 year

Secondary outcomes

  1. Safety of amphotericin B and azoles

    Safety evaluation was mainly based on the incidence of adverse events / adverse reactions in the two groups of patients.

    Time frame: During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for Feb 2025, 45 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2025
First posted
Feb 11, 2025
StartActual
May 1, 2021
Primary completionEst.
Feb 1, 2025
CompletionEst.
Feb 1, 2025
Last update
Feb 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06819410
Lead sponsor
Sichuan Provincial People's Hospital
Responsible party
Lingai Pan (Deputy Chief Physician, Sichuan Provincial People's Hospital) — Principal investigator
First posted
Feb 11, 2025
Start date
May 1, 2021
Primary completion
Feb 1, 2025 (estimated)
Completion
Feb 1, 2025 (estimated)
Last update
Feb 11, 2025

Study contacts

lingai Pan, PhD
Contact
panlingai2004@163.com
17708130236
lingai PP Pan, PhD
study chair · Sichuan Provincial People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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