NL-OMON46362招募中4 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 - Posaconazole prophylaxis for prevention of IAA POSA-F
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 in nasopharyngeal swab (NS), bronchial aspirate (BA) or broncho-alveolar lavage (BAL) fluid within 7 days prior to 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 means of PCR);
- •4. Influenza symptoms present for no more than 10 days prior to ICU admission;
- •5. Respiratory distress as the main reason for ICU admission. Respiratory distress will be defined as tachypnea with a respiratory rate >= 25/min. and a PaO2/FiO2 ratio <= 300 with or without (bilateral) infiltrates on radiographic chest studies
排除标准
- •1. Pregnant women (based on a positive serum sample);
- •2. Expected survival on ICU admission <= 48 hours;
- •3. Patients being transferred from another hospital ward or another hospital who already have mycological evidence of invasive aspergillosis (based on sputum, BA or BAL fluid culture; BAL fluid or serum galactomannan);
- •4. Patients with known intolerance of or hypersensitivity to posaconazole;
- •5. Patients actively treated with antifungal agents active against Aspergillus species;
- •6. Patients actively treated with rifampicin or rifabutin
- •7. Patients with a QTc interval >= 500 milliseconds on electrocardiography (ECG);
- •8. Patients with liver cirrhosis (Child-Pugh classification C);
- •9. Participation in another investigational clinical trial;
- •10. Any disorder which, in the investigator's opinion, might jeopardize subject's safety or compliance with the protocol
研究者
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