EUCTR2007-003472-19-GB进行中(未招募)1 期
Determining a viral load threshold for pre-emptive therapy for cytomegalovirus infection in transplant patients using real time PCR monitoring.
Royal Free Hampstead NHS Trust0 个研究点目标入组 178 人开始时间: 2007年8月1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
- 178
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
入选标准
- •1. All Stem Cell, Renal and Liver Transplant recipients
- •2. Wiling to give informed consent
- •3. A) All patients with CMV viraemia (between 200 and 3000 copies/ml) in the liver, renal and stem cell groups in two consecutive samples.
- •B) Those patients requiring pre-emptive therapy because viral load is > 3,000 copies/ml
- •4. All patients in either section of the study must be available for CMV PCR monitoring at least twice per week.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Profound neutropaenia considered to preclude administration of ganciclovir or profound renal failure considered to preclude administration of foscarnet
- •2. Inability to give informed consent
- •3. In the stem cell group, Donor negative, Recipient negative transplants.
- •4. In the stem cell group: matched unrelated donors who are CMV seronegative
- •5. Those patients who have been in Group A cannot then enter the Group B part of the study.
- •6. Those patients who have been in Group B cannot then enter the Group A part of the study.
研究者
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