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临床试验/NCT07479355
NCT07479355进行中(未招募)不适用

Study of the Characteristics of Acute Mycoplasma Resuscitation: ECRAN-PLASMA Study

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
100
试验地点
1
主要终点
Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae Infections

研究概览

简要总结

The ECRAN-PLASMA study aims to analyze the characteristics of patients with Mycoplasma pneumoniae or Chlamydia pneumoniae pneumonia hospitalized in intensive care units (ICU), continuous monitoring units (USC), or intensive pulmonary care units (USIP). It evaluates their management, prognosis, and macrolide resistance rates.

详细描述

The ECRAN-PLASMA study focuses on Mycoplasma pneumoniae and Chlamydia pneumoniae infections in intensive care units (ICU), continuous monitoring units (USC), and intensive pulmonary care units (USIP). It aims to better understand the epidemiology, management, and prognosis of these infections, particularly in light of the resurgence of cases following the COVID-19 pandemic and the increasing resistance to macrolides.

Mycoplasmas are bacteria lacking a cell wall, making them resistant to beta-lactam antibiotics. M. pneumoniae adheres to the respiratory epithelium and produces a toxin (CARD-TX) that plays a role in disease pathogenesis. Transmission occurs through aerosols and droplets, with its prevalence likely underestimated due to often mild symptoms. However, in elderly or vulnerable patients, the infection can progress to severe forms requiring intensive care hospitalization, with a significant mortality rate.

The study includes all patients hospitalized in USC, USIP, or ICU who test positive for Mycoplasma pneumoniae or Chlamydia pneumoniae during the inclusion period. Its main objectives are to describe patient characteristics, assess factors associated with disease severity and prognosis, and analyze macrolide resistance.

Expected outcomes include estimating the incidence of Mycoplasma pneumoniae and Chlamydia pneumoniae pneumonia in intensive care settings, gaining a better understanding of at-risk patient profiles, and optimizing patient management. The study also aims to improve prevention strategies and guide future clinical research on these infections.

研究设计

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

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

  • Screening of all patients hospitalized in Intermediate Care Units (USC), Intensive Respiratory Care Units (USIP), and Intensive Care Units (ICU)
  • Inclusion of patients who test positive for Mycoplasma pneumoniae or Chlamydia pneumoniae

排除标准

  • Patients under 18 years old

结局指标

主要结局

Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae Infections

时间窗: From hospital admission to hospital discharge (up to 60 days)

Number of patients hospitalized in ICU, USC, or USIP with a confirmed diagnosis of Mycoplasma pneumoniae or Chlamydia pneumoniae.

次要结局

  • In-hospital Mortality Rate(From hospital admission to hospital discharge (up to 60 days))
  • Length of Stay in ICU and Hospital(From hospital admission to hospital discharge (up to 60 days))
  • Macrolide Resistance Rate(At time of microbiological diagnosis (baseline))
  • Need for invasive mechanical ventilation(From hospital admission to hospital discharge (up to 60 days))
  • Use of respiratory and supportive therapies(From hospital admission to hospital discharge (up to 60 days))
  • Time from Symptom Onset to ICU Admission(At patient admission.)
  • In-hospital mortality compared with other bacterial pneumonias(From hospital admission to hospital discharge (up to 60 days))
  • Vital status at hospital discharge(During hospitalization (up to 60 days))
  • Respiratory support at hospital discharge(During hospitalization (up to 60 days))
  • Occurrence of acute respiratory distress syndrome (ARDS)(From hospital admission to hospital discharge (up to 60 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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