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NCT Number: NCT07191756

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangxi Medical University

Nanning, Guangxi, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Amphotericin B

Drug

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

Isavuconazole

Drug

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

Primary outcomes

  1. Overall Survival

    Time frame: From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.

Sponsors and collaborators

Lead sponsor

Qiu Ye

Other

Collaborators

  • Guangzhou Medical University

Registry information

Official study 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

Acronym: AIM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2025
Registry last updated
Sep 25, 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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