跳至主要内容
临床试验/NCT06095076
NCT06095076招募中不适用

Prospective Descriptive Study of the Cutaneous Microbiota of ICU Patients With Central Venous Catheter (ICMc)

Centre Hospitalier de Cayenne1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Evolution of alpha-diversity

研究概览

简要总结

Intensive Care Unit (ICU) patients are exposed to catheter-related infections with an important morbidity. Catheter colonization is constant but infection is not. Cutaneous dysbiosis could be the missing link. Our study aims to evaluate the evolution of cutaneous microbiota in ICU patients with a central venous catheter in place, through metagenomics. Our main objective is to evaluate the evolution of alpha-diversity, quantified by intra-patient variation of Shannon diversity index (a diversity index used in bacterial metagenomics).

详细描述

Central venous catheters (CVCs) are necessary in up to 60% of ICU patients, representing a risk of catheter-related infections with high morbidity and mortality. Catheter colonization originating mostly from the skin is constant, but infection is not. Dysbiosis is known to be associated with pathological states and infection, for example post-antibiotic C. difficile diarrheas, or atopic dermatitis, in which flares are associated with dysbiosis and S. aureus predominance. Cutanous dysbiosis could be the missing link between catheter colonization and infection. Our hypothesis is that under the influence of multiple ICU factors (stress, antibiotic administration, local dysinfection procedures), cutaneous dybiosis appears in ICU patients with a central venous catheter.

All adult ICU patients with an indication for CVC placement will be included over a 6 months period. Skin swabbing will be performed on CVC insertion site before CVC placement (baseline), and then every 3 days (or when dressing is changed) while CVC is in place, then at ICU discharge. Bacterial metagenomics using bacterial DNA extraction, 16S PCR amplification and Nanopore sequencing will allow for description of cutaneous microbiota and diversity evaluation through Shannon index. Evolution of alpha-diversity will be evaluated through time-series data analysis: comparison of Shannon index at various time points with baseline Shanonn index (before CVC placement). Standard microbiologic culture of skin swabbing will be performed. General patient characteristics and informations relative to CVC infection and treatment will be collected.

This study will have no impact on patient management.

Category 3 Non-Interventional Human Person Research (RIPH 3)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Adult hospitalized in ICU at the Cayenne Hospital Center in whom the installation of a CVC is indicated

排除标准

  • Patient under 18 years of age
  • Patient or trusted person or family or relative objecting to participation in the study (refusal)
  • Patient under judicial safeguard or under any other protective regime (guardianship or curatorship)
  • Patient with cutaneous lesions (infection, burn) near the cutaneous insertion site of the CVC

结局指标

主要结局

Evolution of alpha-diversity

时间窗: Day 3

Comparison of Shannon index at various time points with baseline Shannon index (before Central Venous Catheter placement through leaving intensive care service). The higher the Shannon index, the greater the diversity.

次要结局

  • Skin colonization(Day 3)
  • Skin swabs Metagenomics(Day 3)
  • Central Venous Catheter's Metagenomics(Day 3)
  • Catheter related Infection(Day 3)
  • Catheter-related colonization(Day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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