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临床试验/NCT05077150
NCT05077150已完成不适用

A Case-control Study on Risk Factors, Timing, and PCR Use, for Pneumocystis Pneumonia (PcP) After Allogeneic HSCT

European Society for Blood and Marrow Transplantation9 个研究点 分布在 6 个国家目标入组 168 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
9
主要终点
Post-transplant risk factors for PCP infection

研究概览

简要总结

The fungus Pneumocystis jirovecii is responsible for pneumocystosis (PcP), a life threatening pneumonia in patients undergoing HSCT. The spontaneous attack rate of 16% within the first 6 months following allogeneic HSCT reported in the 1980's has considerably decreased with prophylaxis. However, PcP still remains a concern in the transplant ward with an incidence rate up to 2.5% in allo- and 1.4% in autologous HSCT but up to 7.2% on low dose of Dapsone. The mortality of PcP is especially high in HSCT recipients. One of the main factors of PcP after HSCT seems to be either the lack of TMP-SMX prophylaxis (all the other prophylactic drugs being inferior to TMP-SMX), or poor compliance to prophylaxis. Due to the rarity of the disease after HSCT, it is impossible to study it in monocenter studies, except on very long periods of time which may not reflect current practice. Several questions deserve investigations in a multicenter study, about timing, risk factors, and outcome.

Moreover, some European laboratories involved in the diagnosis of PcP have already given up to classical diagnostic methods and switched to qPCR. This implies that lower fungal burden can be detected and the clinical pertinence of such a diagnostic strategy deserves to be assessed.

详细描述

Due to the lack of standardization, qPCR on sputum only will not be taken in account for the diagnosis of PcP. Knowing this is a non-interventional study, no additional visits or laboratory tests will be performed for the study. Only the available data will be collected.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Post-transplant risk factors for PCP infection

时间窗: 90 days

To identify pre- and post-transplant factors associated with development of PcP after allogeneic HSCT including: Underlying disease, graft versus host disease, relapse of underlying disease, immune status, co-infections, age

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (9)

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