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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Other: Infectious disease epidemiology

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• France
  • Le Kremlin-Bicêtre, France
    • Medecine intensive-reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae Infections	Number of patients hospitalized in ICU, USC, or USIP with a confirmed diagnosis of Mycoplasma pneumoniae or Chlamydia pneumoniae.	From hospital admission to hospital discharge (up to 60 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital Mortality Rate	Proportion of patients who died during the index hospitalization among patients with confirmed infection, assessed from medical records.	From hospital admission to hospital discharge (up to 60 days)
Length of Stay in ICU and Hospital	Number of days spent in the ICU and total hospitalization duration.	From hospital admission to hospital discharge (up to 60 days)
Macrolide Resistance Rate	Percentage of patients infected with a macrolide-resistant strain.	At time of microbiological diagnosis (baseline)
Need for invasive mechanical ventilation	Proportion of patients requiring invasive mechanical ventilation during hospitalization, assessed from medical records.	From hospital admission to hospital discharge (up to 60 days)
Use of respiratory and supportive therapies	Proportion of patients receiving each therapeutic modality (oxygen therapy, non-invasive ventilation, invasive mechanical ventilation, ECMO) during hospitalization, assessed from medical records.	From hospital admission to hospital discharge (up to 60 days)
Time from Symptom Onset to ICU Admission	Time elapsed between the onset of symptoms and hospitalization in USC, USIP, or ICU.	At patient admission.
In-hospital mortality compared with other bacterial pneumonias	Difference in in-hospital mortality rates between patients with Mycoplasma or Chlamydia pneumoniae infection and patients with other bacterial pneumonias, assessed from medical records.	From hospital admission to hospital discharge (up to 60 days)
Vital status at hospital discharge	Proportion of patients alive at hospital discharge, assessed from medical records.	During hospitalization (up to 60 days)
Respiratory support at hospital discharge	Proportion of patients requiring respiratory support (oxygen therapy or mechanical ventilation) at hospital discharge, assessed from medical records.	During hospitalization (up to 60 days)
Occurrence of acute respiratory distress syndrome (ARDS)	Proportion of patients who developed acute respiratory distress syndrome during hospitalization, assessed from medical records.	From hospital admission to hospital discharge (up to 60 days)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Infection; Chlamydia pneumoniae; Mycoplasma pneumoniae; Intensive Care Unit (ICU); Intensive Respiratory Care Unit (USIP); Intermediate Care Unit (USC)
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Infections
• Other Study ID Numbers: APHP240404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No