Negative Beta Glucan in ICU Patients
关键词
抽象
描述
Entry criteria are: In the ICU for >2 days AND systemic antibiotics >2 days OR central venous catheter for >days AND at least two of the following: total parenteral nutrition, dialysis, surgery, pancreatitis, receipt of corticosteroids, receipt of other immunosuppressive agents. In addition, patients must have a clinical sign of infection (either one of the following): fever, hypothermia, hypotension, unexplained acidosis, or unexplained elevation in C-reactive protein.
Eligible patients will be enrolled after signing an informed consent and will have blood obtained for culture and determination of 1,3 beta-D-glucan serum levels for 3 days, and will start anidulafungin IV.
If all tests are negative, anidulafungin will be discontinued on day 4. If 1,3 beta-D-glucan is positive (>80 pg/ml) and / or blood cultures are positive for Candida species, anidulafungin will be continued for >14 days.
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 11/19/2012 |
| 提交的预估入学人数: | 11/25/2012 |
| 首次发布: | 11/26/2012 |
| 上次提交的更新: | 04/17/2019 |
| 最近更新发布: | 07/07/2019 |
| 首次提交结果的日期: | 11/29/2015 |
| 首次提交质量检查结果的日期: | 04/17/2019 |
| 首次发布结果的日期: | 07/07/2019 |
| 实际学习开始日期: | 10/31/2012 |
| 预计主要完成日期: | 11/30/2013 |
| 预计完成日期: | 11/30/2013 |
状况或疾病
干预/治疗
Drug: Anidulafungin
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Anidulafungin Patients at risk will receive therapy with anidulafungin | Drug: Anidulafungin Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - In the ICU for >2 days AND - Systemic antibiotics on days 1-3 of ICU OR - Central venous catheter on days 1-3 of ICU - AND at least 2 of: - Total parenteral nutrition on days 1-3 of ICU - Any dialysis on days 1-3 of ICU - Major surgery in the 7 days before admission in the ICU - Pancreatitis in the 7 days before admission in the ICU - Use of corticosteroids for at least 3 days in the 7 days before admission - Use of other immunosuppressive agents in the 7 days before admission in the ICU - In addition, the patient must have at least one of the following: - Fever (axillary temperature >37.5 oC) - Hypothermia (axillary temperature <35 oC) - Hypotension - Unexplained acidosis - Unexplained elevation in C-reactive protein Exclusion Criteria: - Antifungal for >3 days - Allergy to an echinocandin |
结果
主要结果指标
1. Evaluate the Ocurrence of Candidemia in Patients With Negative 1,3 Beta-D-glucan Who Discontinue Anidulafungin [30 days]
