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NCT Number: NCT07479355

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medecine intensive-reanimation

Le Kremlin-Bicêtre, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients under 18 years old

Treatment and study plan

Infectious disease epidemiology

Other

evaluation of patient management, prognosis, and macrolide resistance rates in severe Mycoplasma pneumoniae and Chlamydia pneumoniae infections.

Primary outcomes

  1. Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae Infections

    Time frame: 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.

Secondary outcomes

  1. In-hospital Mortality Rate

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Proportion of patients who died during the index hospitalization among patients with confirmed infection, assessed from medical records.

  2. Length of Stay in ICU and Hospital

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Number of days spent in the ICU and total hospitalization duration.

  3. Macrolide Resistance Rate

    Time frame: At time of microbiological diagnosis (baseline)

    Percentage of patients infected with a macrolide-resistant strain.

  4. Need for invasive mechanical ventilation

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Proportion of patients requiring invasive mechanical ventilation during hospitalization, assessed from medical records.

  5. Use of respiratory and supportive therapies

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Proportion of patients receiving each therapeutic modality (oxygen therapy, non-invasive ventilation, invasive mechanical ventilation, ECMO) during hospitalization, assessed from medical records.

  6. Time from Symptom Onset to ICU Admission

    Time frame: At patient admission.

    Time elapsed between the onset of symptoms and hospitalization in USC, USIP, or ICU.

  7. In-hospital mortality compared with other bacterial pneumonias

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Difference in in-hospital mortality rates between patients with Mycoplasma or Chlamydia pneumoniae infection and patients with other bacterial pneumonias, assessed from medical records.

  8. Vital status at hospital discharge

    Time frame: During hospitalization (up to 60 days)

    Proportion of patients alive at hospital discharge, assessed from medical records.

  9. Respiratory support at hospital discharge

    Time frame: During hospitalization (up to 60 days)

    Proportion of patients requiring respiratory support (oxygen therapy or mechanical ventilation) at hospital discharge, assessed from medical records.

  10. Occurrence of acute respiratory distress syndrome (ARDS)

    Time frame: From hospital admission to hospital discharge (up to 60 days)

    Proportion of patients who developed acute respiratory distress syndrome during hospitalization, assessed from medical records.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ECRAN-PLASMA

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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