Post-marketing Surveillance (PMS) Management of Invasive Mycosis With Posaconazole
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 主要终点
- Number of Participants Reporting Adverse Drug Reactions.
研究概览
简要总结
The purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of NOXAFIL® (posaconazole) in the treatment of invasive fungal disease.
详细描述
Data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs & symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic Case Report Forms.
This surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. A subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for NOXAFIL® (posaconazole) during the course of the study. These participants only contributed data for the assessment of safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects with:
- •Invasive aspergillosis refractory to, or intolerant of, amphotericin B or itraconazole,
- •Fusariosis refractory to, or intolerant of, amphotericin B,
- •Chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole,
- •Coccidiomycosis refractory to, or intolerant of, amphotericin B, itraconazole or fluconazole.
- •Subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections.
- •Hematopoietic stem-cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for Graft-versus-host disease and who are at high risk for developing invasive fungal infections.
排除标准
- •Comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
研究组 & 干预措施
Posaconazole (assigned by physician in normal practice)
- Treatment of invasive fungal infection.
- Prophylaxis of invasive fungal infection.
干预措施: Posaconazole (Drug)
结局指标
主要结局
Number of Participants Reporting Adverse Drug Reactions.
时间窗: Before starting treatment with posaconazole, during treatment, and until 100 days after treatment.
The severity of an Adverse Drug Reaction is determined on the basis of the following definitions: Mild: The abnormality, symptom or event is noticed but well tolerated. Moderate: Symptoms impair normal activities and may require intervention. Severe: Clinical status is significantly impaired, normal activity is no longer possible, intervention is required.
次要结局
未报告次要终点