ISRCTN11401066已完成4 期
VACIRISS: pneumococcal Vaccination to ACcelerate Immune Recovery In Sepsis Survivors: a randomized placebo-controlled trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 214
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
- 性别
- All
入选标准
- •1. Aged 18 years or older at screening
- •2. Registered with a General Practitioner
- •3. Admitted to intensive care unit or high dependence unit for sepsis (sepsis is defined as suspected or proven infection with a total Sepsis-related Organ Failure Assessment (SOFA) score of at least 2 points)
- •4. Improved clinical condition
- •5. Ready for step down to high dependence unit or ward-based care in the next 24-48 hours
- •6. Patient or their legal representative is able to provide written informed consent
排除标准
- •1. Core temperature 38.0 °C or higher within the past 24 hours prior to study investigational medicinal product (IMP) administration
- •2. Hypersensitivity reaction (i.e. anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine
- •3. Vaccination administered to patient within 7 days of enrolment
- •4. Pregnant or lactating women
- •5. Limitations of care set, including not for resuscitation, not for readmission to critical care
- •6. Resident of nursing home, long-term care facility or other institution, or requirement of semi-skilling nursing care
- •7. Coagulopathy, defined as at least one of the following:
- •7.1. Platelet count less than 50 x 109/L
- •7.2. International normalized ratio (INR) greater than 1.3
- •8. APACHE II score-defined immune deficiency or supression, defined as at least one of the following conditions:
- •8.1. Documented human immunodeficiency virus (HIV) infection at any timepoint prior to the trial (if previous results are not available and/or current admission is not due to HIV infection, these patients do not need new testing and are considered eligible for the trial)
- •8.2. Leukaemia, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
- •8.3. Lymphoma, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
- •8.4. Hodgkin disease, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
- •8.5. Multiple myeloma, defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
- •8.6. Malignancy, defined as presence of any malignancy that had been treated by or had been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years
- •8.7. Chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
- •8.8. Receipt of immunosuppressive therapy, including steroids, within 3 months of study vaccine administration (For corticosteroids, prednisone or equivalent 0.5 mg/kg/day for 14 days or longer. Inhaled, intra- articular, and topical steroids are not considered immunosuppressive)
研究者
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