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| Name | Class |
|---|---|
| Guangzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Medical University | Nanning | Guangxi | China |
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| ID | Term |
|---|---|
| D009091 | Mucormycosis |
| ID | Term |
|---|---|
| D020096 | Zygomycosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000666 | Amphotericin B |
| C508735 | isavuconazole |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Isavuconazole | Drug | This is a retrospective observational study. Patients in this cohort received isavuconazole as part of their standard medical care. |
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