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

NCT07191756 | Active Not Recruiting FDA Drug

• 1 other identifier: 2025-AMB-ISA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mucormycosis

Keywords

Amphotericin B; isavuconazole; mucormycosis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

Study Arms (2)

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.

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.

Drug: Isavuconazole

Interventions

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.

Amphotericin B Cohort

Isavuconazole DRUG

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

Isavuconazole Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qiu Ye: lead
• Guangzhou Medical University: collaborator

Study Sites (1)

Guangxi Medical University

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Mucormycosis

Interventions

Amphotericin B; isavuconazole

Condition Hierarchy (Ancestors)

Zygomycosis; Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: May 15, 2025
• Primary Completion: July 21, 2025
• Study Completion: September 25, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

CN (1)