MucormycosisAIMNCT07191756
Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study
An observational study of Mucormycosis, run by Qiu Ye at 1 site in China.
Trial summary
Background: Mucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole. However, more real-world data is needed to directly compare how well they work and how safe they are for patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mucormycosis
- What is being tested?
- Amphotericin B and Isavuconazole
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2025to 25 Sep 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: This study will analyze a retrospective cohort of patients with a confirmed diagnosis of mucormycosis who were treated at one of three participating hospitals. The study population will be divided into two groups based on the primary antifungal therapy they received: (1) those who received amphotericin B-based therapy (any formulation), and (2) those who received isavuconazole. Data from eligible patients' medical records will be extracted to form the final study dataset. Additionally, relevant patient data from studies identified via a systematic PubMed literature review may be included to supplement the analysis.
Who may be able to join
- Confirmed diagnosis of mucormycosis based on histopathology, culture, or typical radiographic findings in accordance with established guidelines.
- Received primary antifungal treatment for mucormycosis with either amphotericin B (any formulation) or isavuconazole for at least 48 hours.
- Had at least one follow-up assessment after initiation of antifungal therapy to evaluate treatment response.
- Medical records from the participating hospitals are sufficiently complete for data extraction regarding treatment and outcomes.
Who cannot join
- Patients who were not treated with amphotericin B or isavuconazole; and patients who did not have mucormycosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Multicenter Cohort Study Comparing the Efficacy and Safety of Amphotericin B Versus Isavuconazole for the Treatment of Mucormycosis: Analysis of Institutional Data and Literature Review
Background:
Mucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole. However, more real-world data is needed to directly compare how well they work and how safe they are for patients.
Read more
What is the purpose of this study? The main goal of this research study is to compare the effectiveness and safety of amphotericin B versus isavuconazole in treating mucormycosis. Investigators will look at which medicine leads to better survival rates and fewer serious side effects.
How will the study be done? This is a retrospective study. This means investigators will look back at information that has already been collected. Investigators will analyze data from the medical records of patients who were treated for mucormycosis at three hospitals. Investigators will also review and combine findings from relevant studies published on PubMed.
What will the researchers measure?
Investigators will measure and compare:
How long patients survived after treatment (survival rates).
Whether the infection was successfully cured or controlled (treatment response).
What kinds of side effects (like kidney problems or liver issues) patients experienced with each medicine.
What are the possible benefits of this study? This study will not directly benefit the participants whose records are reviewed. However, investigators hope that what investigators learn will help doctors make better treatment decisions for future patients with mucormycosis by providing clearer evidence on the best choice of medicine.
- Conditions
- Mucormycosis
- Being tested
- Amphotericin B, Isavuconazole
- Keywords
- Amphotericin B, isavuconazole, mucormycosis
- Medical subject headings
- Mucormycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphotericin BDrug
This is a retrospective observational study. Patients in this cohort received various formulations of amphotericin B as part of their standard medical care.
IsavuconazoleDrug
This is a retrospective observational study. Patients in this cohort received isavuconazole as part of their standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B Cohort | Patients with a confirmed diagnosis of mucormycosis who received primary treatment with any formulation of amphotericin B (e.g., liposomal amphotericin B, amphotericin B deoxycholate) during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals. Receives: Drug: Amphotericin B | |
| Isavuconazole Cohort | Patients with a confirmed diagnosis of mucormycosis who received primary treatment with isavuconazole during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals. Receives: Drug: Isavuconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start15 May 2025
- Primary completion21 Jul 2025
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucormycosisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qiu Ye
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Medical University
- Responsible party
- Sponsor-investigator, Qiu Ye, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191756
- Sponsor's protocol ID
- 2025-AMB-ISA
- Acronym
- AIM
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Multicenter Cohort Study Comparing the Efficacy and Safety of Amphotericin B Versus Isavuconazole for the Treatment of Mucormycosis: Analysis of Institutional Data and Literature Review
- ClinicalTrials.gov ID
- NCT07191756
- Acronym / sponsor ID
- AIM / 2025-AMB-ISA
- Conditions
- Mucormycosis
- Keywords
- Amphotericin B, isavuconazole, mucormycosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Qiu YeUniversity, hospital or other
- Collaborators
- Guangzhou Medical University
- Study start
- 15 May 2025 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 25 Sep 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.
Background:
Mucormycosis is a serious but rare fungal infection that requires rapid and effective treatment. The two main antifungal medicines used are amphotericin B and isavuconazole. However, more real-world data is needed to directly compare how well they work and how safe they are for patients.
What is the purpose of this study? The main goal of this research study is to compare the effectiveness and safety of amphotericin B versus isavuconazole in treating mucormycosis. Investigators will look at which medicine leads to better survival rates and fewer serious side effects.
How will the study be done? This is a retrospective study. This means investigators will look back at information that has already been collected. Investigators will analyze data from the medical records of patients who were treated for mucormycosis at three hospitals. Investigators will also review and combine findings from relevant studies published on PubMed.
What will the researchers measure?
Investigators will measure and compare:
How long patients survived after treatment (survival rates).
Whether the infection was successfully cured or controlled (treatment response).
What kinds of side effects (like kidney problems or liver issues) patients experienced with each medicine.
What are the possible benefits of this study? This study will not directly benefit the participants whose records are reviewed. However, investigators hope that what investigators learn will help doctors make better treatment decisions for future patients with mucormycosis by providing clearer evidence on the best choice of medicine.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B Cohort | – | Drug: Amphotericin BPatients with a confirmed diagnosis of mucormycosis who received primary treatment with any formulation of amphotericin B (e.g., liposomal amphotericin B, amphotericin B deoxycholate) during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals. |
| Isavuconazole Cohort | – | Drug: IsavuconazolePatients with a confirmed diagnosis of mucormycosis who received primary treatment with isavuconazole during the study period. Treatment details, including dosage and duration, were collected from retrospective review of electronic medical records from three participating hospitals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will analyze a retrospective cohort of patients with a confirmed diagnosis of mucormycosis who were treated at one of three participating hospitals. The study population will be divided into two groups based on the primary antifungal therapy they received: (1) those who received amphotericin B-based therapy (any formulation), and (2) those who received isavuconazole. Data from eligible patients' medical records will be extracted to form the final study dataset. Additionally, relevant patient data from studies identified via a systematic PubMed literature review may be included to supplement the analysis.
Key inclusion criteria (4 listed)
- Confirmed diagnosis of mucormycosis based on histopathology, culture, or typical radiographic findings in accordance with established guidelines.
- Received primary antifungal treatment for mucormycosis with either amphotericin B (any formulation) or isavuconazole for at least 48 hours.
- Had at least one follow-up assessment after initiation of antifungal therapy to evaluate treatment response.
- Medical records from the participating hospitals are sufficiently complete for data extraction regarding treatment and outcomes.
Key exclusion criteria (1 listed)
- Patients who were not treated with amphotericin B or isavuconazole; and patients who did not have mucormycosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amphotericin BThis is a retrospective observational study. Patients in this cohort received various formulations of amphotericin B as part of their standard medical care. | Drug | Amphotericin B Cohort |
| IsavuconazoleThis is a retrospective observational study. Patients in this cohort received isavuconazole as part of their standard medical care. | Drug | Isavuconazole Cohort |
Primary outcome
Overall Survival
Time frame: From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.
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 25 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Mucormycosis, run by Qiu Ye 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.). 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 25 Sep 2025.