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临床试验/NCT04874441
NCT04874441已完成不适用

Evaluation of the Effect of the Implementation of a Candida PCR Diagnosis Strategy on the Time Required to Obtain Results in Patients From Intensive Care Units With Suspected Systemic Invasive Candidiasis: Pilot Study

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年5月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Reporting delay

研究概览

简要总结

The aim of this study is to evaluate the implementation of a new technique for invasive candidiasis diagnosis by PCR. The main objective will be to evaluate the effect of this strategy on the time required to obtain results in patients from intensive care units with suspected systemic invasive candidiasis. This PCR method could allow an antifungal switch to be made earlier, limiting the appearance of resistance and reducing the cost of antifungals for healthcare facilities.

详细描述

Invasive candidiasis is a serious infection caused by yeasts of the genus Candida sp. Their incidence is increasing, particularly in intensive care. The prognosis is severe and depends on the early initiation of adequate antifungal treatment. At present, the diagnosis of invasive candidiasis is difficult since blood culture, the reference technique, has major limitations due to its low sensitivity, as well as very long delays in obtaining results. As a consequence, suspected invasive candidiasis is often treated empirically with echinocandins, resulting in the development of resistance and extremely high costs for health care facilities. The switch to treatments such as fluconazole is often delayed, although this molecule is effective on most Candida species except C. krusei and glabrata and is much less expensive than echinocandins.

For these reasons, the present study developed faster and more efficient methods to diagnose Candida krusei and glabrata species, based on the detection of DNA in the blood by PCR, allowing an earlier switch from echinocandins to Fluconazole.

The patients included will be divided into 2 groups: one group of patients will benefit from a diagnostic strategy based on blood culture (reference technique for the detection of Candida) and another group of patients will benefit from a diagnostic strategy based on this new PCR technique. The main objective will be to evaluate the effect of the PCR strategy on the time to obtain results and on the switch of antifungal agents. After inclusion, patients will be followed up at day 14, day 28 until discharge (or 3 months if the patient is still hospitalised).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient affiliated or benefiting from a social protection system
  • •Patient (or his/her trusted person) having given free and informed written consent to the investigating physician
  • •Non-neutropenic patient hospitalised in the Toulouse University Hospital intensive care unit.
  • •Patient with suspected invasive candidiasis for whom a blood culture for fungal infection diagnosis was taken and for whom an empirical treatment with echinocandin at an adapted dose was implemented.

排除标准

  • •Patients under guardianship or trusteeship, persons under court protection
  • •Pregnant or breastfeeding patients.

研究组 & 干预措施

blood culture-based diagnostic strategy

No Intervention

Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a blood culture-based diagnostic strategy

C. glabrata / krusei PCR diagnostic strategy

Experimental

Patients from intensive care units with suspected invasive candidiasis initially treated with echinocandins and who benefited from a diagnostic strategy based on C. glabrata / krusei PCR

干预措施: Diagnosis strategy based on C. glabrata / krusei PCR (Diagnostic Test)

结局指标

主要结局

Reporting delay

时间窗: 14 days after blood sample taken

the time (in hours) required for the results to be returned in relation to the time of sample collection

次要结局

  • mortality at Day 28(28 days after blood sample taken)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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