Invasive Fungal DiseaseNCT06819410
Efficacy and Safety of Amphotericin B and Azoles in the Treatment of Invasive Fungal Disease
An observational study of Invasive Fungal Disease, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
Efficacy and safety of amphotericin B and azoles in the treatment of invasive fungal disease Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Fungal Disease
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 1 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
lingai Pan, PhD, 17708130236, panlingai2004@163.com
About this study
Official title: 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
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.
- Conditions
- Invasive Fungal Disease
- Medical subject headings
- Invasive Fungal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the treatment (1-14 days); the end of treatment (Day 14);Day 28 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 May 2021
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Fungal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
- Investigators
- lingai PP Pan, PhD, Study chair, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819410
- Sponsor's protocol ID
- Lunshen(Research)No.818,2024
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Clinical Study on the Efficacy and Safety of Amphotericin B Compared With Azoles in the Treatment of Invasive Fungal Disease
- ClinicalTrials.gov ID
- NCT06819410
- Acronym / sponsor ID
- Lunshen(Research)No.818,2024
- Conditions
- Invasive Fungal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety of amphotericin B and azoles in the treatment of invasive fungal disease
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with invasive fungal disease who are treated with polyene antifungals or azole antifungals should be treated for ≥ 7 days.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
lingai PP Pan, PhD study chair
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Disease, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lingai Pan, PhD (17708130236, panlingai2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate (time frame: The end of treatment, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.