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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07479355
Acronym
ECRAN-PLASMA
Enrollment
100
Registered
2026-03-18
Start date
2024-09-15
Completion date
2026-06-15
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

Intensive Care Unit (ICU), Intensive Respiratory Care Unit (USIP), Intermediate Care Unit (USC), Chlamydia pneumoniae, Mycoplasma pneumoniae, Infection

Brief summary

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.

Detailed description

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.

Interventions

OTHERInfectious disease epidemiology

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae InfectionsFrom 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

MeasureTime frameDescription
In-hospital Mortality RateFrom 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.
Length of Stay in ICU and HospitalFrom hospital admission to hospital discharge (up to 60 days)Number of days spent in the ICU and total hospitalization duration.
Macrolide Resistance RateAt time of microbiological diagnosis (baseline)Percentage of patients infected with a macrolide-resistant strain.
Need for invasive mechanical ventilationFrom hospital admission to hospital discharge (up to 60 days)Proportion of patients requiring invasive mechanical ventilation during hospitalization, assessed from medical records.
Use of respiratory and supportive therapiesFrom 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.
Time from Symptom Onset to ICU AdmissionAt patient admission.Time elapsed between the onset of symptoms and hospitalization in USC, USIP, or ICU.
In-hospital mortality compared with other bacterial pneumoniasFrom 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.
Vital status at hospital dischargeDuring hospitalization (up to 60 days)Proportion of patients alive at hospital discharge, assessed from medical records.
Respiratory support at hospital dischargeDuring hospitalization (up to 60 days)Proportion of patients requiring respiratory support (oxygen therapy or mechanical ventilation) at hospital discharge, assessed from medical records.
Occurrence of acute respiratory distress syndrome (ARDS)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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026