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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who were not treated with amphotericin B or isavuconazole; and patients who did not have mucormycosis.
研究组 & 干预措施
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.
干预措施: Amphotericin B (Drug)
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.
干预措施: Isavuconazole (Drug)
结局指标
主要结局
Overall Survival
时间窗: From date of diagnosis until the date of death from any cause, whichever occurred first, assessed up to 12 months.
次要结局
未报告次要终点
研究者
Qiu Ye
PhD
Guangxi Medical University