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Amphotericin B Versus Isavuconazole for Mucormycosis: A Comparative Efficacy and Safety Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07191756
Acronym
AIM
Enrollment
150
Registered
2025-09-25
Start date
2025-05-15
Completion date
2025-09-25
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mucormycosis

Keywords

Amphotericin B, isavuconazole, mucormycosis

Brief 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. 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.

Interventions

DRUGAmphotericin B

This is a retrospective observational study. Patients in this cohort received various formulations of amphotericin B as part of their standard medical care.

DRUGIsavuconazole

This is a retrospective observational study. Patients in this cohort received isavuconazole as part of their standard medical care.

Sponsors

Guangzhou Medical University
CollaboratorOTHER
Qiu Ye
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Confirmed diagnosis of mucormycosis based on histopathology, culture, or typical radiographic findings in accordance with established guidelines. 2. Received primary antifungal treatment for mucormycosis with either amphotericin B (any formulation) or isavuconazole for at least 48 hours. 3. Had at least one follow-up assessment after initiation of antifungal therapy to evaluate treatment response. 4. Medical records from the participating hospitals are sufficiently complete for data extraction regarding treatment and outcomes.

Exclusion criteria

* Patients who were not treated with amphotericin B or isavuconazole; and patients who did not have mucormycosis.

Design outcomes

Primary

MeasureTime frame
Overall SurvivalFrom date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026