A Randomized Controlled Trial of Combined Inhalational With Intravenous Amphotericin B in Comparison With Intravenous Amphotericin B Alone for Treatment of Pulmonary Mucormycosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall response (clinical and radiological improvement) at the end of six weeks of start of therapy
研究概览
简要总结
To assess the safety and feasibility of combined inhalational and intravenous amphotericin B therapy for the treatment of pulmonary mucormycosis. And compare the efficacy of combined therapy with that of intravenous amphotericin B alone.
详细描述
Pulmonary mucormycosis is a relatively a rare disease with a high mortality. The angioinvasion associated with mucormycosis prevents efficient drug delivery at the diseased site. Inhaled amphotericin B achieves drug levels in lung tissue and has been shown to be useful in several diseases including chronic pulmonary and allergic bronchopulmonary aspergillosis. Further inhaled forms of amphotericin B are associated with less nephrotoxicity and other systemic adverse effects. The role of inhaled amphotericin B in pulmonary mucormycosis has been previously demonstrated in murine models and anecdotal reports. The study hypothesis is that combined therapy with inhalational and intravenous amphotericin B is likely to result in better outcomes as compared with intravenous amphotericin B alone for treatment of pulmonary mucormycosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with a clinicoradiologic suspicion of pulmonary mucormycosis will be enrolled if the diagnosis of mucormycosis is pathologically or microbiologically (smear showing aseptate hyphae, culture or molecular evidence showing Mucorales) confirmed. Cases of disseminated mucormycosis will be included, only if the pulmonary infection is confirmed pathologically or microbiologically from respiratory secretions or biopsy samples
排除标准
- •Lack of informed consent
- •Hypersensitivity to amphotericin B or any component of the formulation
- •Pregnancy
- •High likelihood of death within 48 h of enrolment
- •Suspected pulmonary mucormycosis without histological or microbiologic proof
研究组 & 干预措施
Intervention arm
The study participants in the intervention arm will receive nebulization with amphotericin B deoxycholate (10 mg twice a day every alternate day, as described below) along with intravenous liposomal amphotericin B (3 to 5 mg/kg body weight)
干预措施: Inhaled amp B deoxycholate+intravenous liposomal amp B (Drug)
Intervention arm
The study participants in the intervention arm will receive nebulization with amphotericin B deoxycholate (10 mg twice a day every alternate day, as described below) along with intravenous liposomal amphotericin B (3 to 5 mg/kg body weight)
干预措施: Intravenous liposomal amphotericin B alone (Drug)
Conventional arm
Participants will receive treatment with only intravenous liposomal amphotericin B (3 to 5 mg/kg body weight)
干预措施: Intravenous liposomal amphotericin B alone (Drug)
结局指标
主要结局
Overall response (clinical and radiological improvement) at the end of six weeks of start of therapy
时间窗: 6 weeks after the start of therapy
Complete response: Survival and resolution of all attributable symptoms and signs of disease plus Resolution of radiological lesion(s); persistence of only a scar or postoperative changes can be equated with complete radiological response Partial response: Survival and improvement of attributable symptoms and signs of disease plus At least 25% reduction in diameter of radiological lesion OR In cases of radiological stabilization (defined as 0%-25% reduction in the diameter), resolution of all attributable symptoms and signs of fungal disease can be equated with a partial response Stable response: Survival and minor or no improvement in attributable symptoms and signs; plus Radiological stabilization (defined as 0%-25% reduction in diameter) Progression: Worsening clinical symptoms or signs plus New sites of disease or radiological worsening Death Complete and partial response will be called "success"
Adverse events related to therapy
时间窗: till 6 weeks from randomization (start of therapy)
Adverse events related to therapy (especially, incidence of bronchospasm and acute kidney injury)
次要结局
- In-hospital mortality(During hospital stay, approximately till 6 weeks from randomization (start of therapy))
- 90 day mortality(90 days from the date of randomization)
- Proportion of subjects requiring discontinuation or modification of therapy due to adverse events(till 6 weeks from randomization (start of therapy))
研究者
Ritesh Agarwal
Professor
Post Graduate Institute of Medical Education and Research, Chandigarh