EUCTR2010-024646-30-GB进行中（未招募）1 期
Anti-viral prophylaxis for prevention of cytomegalovirus (CMV) reactivation in immunocompetent patients in critical care. - Antiviral Prophylaxis to Prevent Cytomegalovirus Reactivation in IT
niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 124 人开始时间: 2011年1月24日最近更新:
适应症
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
- 124
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
- •Total hospital stay of less than 7 days •This study aims to assess prophylaxis to prevent CMV reactivation. Patients screened for inclusion will include those hospitalised for less than 7 days prior to admission to intensive care in order to minimise the inclusion of patients admitted late on in their disease process, with pre-existing critical illness CMV reactivation. Inpatients deemed medically fit in the 7 days prior to ICU admission, eg rehab wards will be accepted for study inclusion CMV seropositive •Patients testing CMV positive only will be approached for inclusion in the interventional arm of the study. Patients testing CMV negative will enter the observational arm of the study, and no patient identifiers will be retained. ICU stay of >48 hours •Patient recruitment will be deferred until the end of a 24hr period on the ICU. This period is essential in order to develop a rapport with the patient and family as part of the consent process, to obtain results of CMV status assays, and to make an assessment regarding suitability of the patient for inclusion in the study. Mechanically ventilated, anticipated to continue for > 48 hours •In order to minimise the numbers of patients receiving therapy unnecessarily, and maximise the likelihood of identifying a clinical effect, the study group selects patients with higher risk of reactivation based on previous publications.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 141
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Age <18 years Pregnancy or breast feeding Expected to survive < 48hrs Confirmed immunosuppression •Known or suspected Human Immunodeficiency Virus infection •Known or suspected underlying immunodeficiency (organ transplant, congenital immunodeficiency, in receipt of immunosuppressive medication e.g. azathioprine, tacrolimus, cyclosporine, sirolimus, cyclophosphamide within 30 days, steroids allowed up to 10mg prednisolone/day on average over 30 days, or stress dose hydrocortisone at up to 400mg/day, short doses of steroids allowed for up to 10 days. •Receipt of chemotherapeutic agent within the last 6 months Severe neutropenia (neutophil count <1000/mm3) Use of systemic antiviral medication within the last 7 days Allergy to study drugs Isolated brain injury
研究者
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