EUCTR2017-003270-14-BE进行中（未招募）1 期
A phase IV, interventional, non-blinded, randomized, controlled, multicenter study of Posaconazole prophylaxis for the prevention of influenza-associated aspergillosis (IAA) in critically ill patients
Z Leuven0 个研究点目标入组 100 人开始时间: 2017年9月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Written informed consent must be obtained from the patient or his/her legal representative prior to any study procedures
- •2.Adult patient (= 18 years)
- •3.PCR-confirmed influenza based on nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) within 7 days before ICU admission or within 48 hours after ICU admission. If PCR is not available a positive result of a rapid test is required (a negative rapid test does not imply absence of influenza and thus requires confirmation by PCR)
- •4.Influenza symptoms present for no more than 10 days before ICU admission
- •5.Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with an respiratory rate = 25x/min and a paO2/fiO2-ration = 300 with or without (bilateral) infiltrates.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Patients with age < 18 years
- •2.Pregnant women (based on a positive serum sample)
- •3.Expected survival on ICU admission = 48h
- •4.Patients having influenza symptoms for more than 10 days before ICU admission
- •5.Patients being transferred from another hospital ward or another hospital who already have mycological evidence for an IAA-infection (based on sputum, BA or BAL culture, BAL or serum GM)
- •6.Patients with known intolerance or hypersensitivity to posaconazole or other azole antifungal agents
- •7.Patients that are being treated actively with antifungal agents for invasive aspergillosis
- •8.Patients with a QTc interval =500 msec
- •9.Patients with liver cirrhosis (Child C)
- •10.Participation in another interventional clinical trial
- •11.Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol
- •12.Patients or their legal representatives who did not sign the informed consent form
研究者
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