PneumoniaECRAN-PLASMANCT07479355
Study of the Characteristics of Acute Mycoplasma Resuscitation: ECRAN-PLASMA Study
An observational study of Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Infectious disease epidemiology
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2024to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients under 18 years old
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Infectious disease epidemiology
- Keywords
- Intensive Care Unit (ICU), Intensive Respiratory Care Unit (USIP), Intermediate Care Unit (USC), Chlamydia pneumoniae, Mycoplasma pneumoniae, Infection
- Medical subject headings
- Pneumonia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infectious disease epidemiologyOther
evaluation of patient management, prognosis, and macrolide resistance rates in severe Mycoplasma pneumoniae and Chlamydia pneumoniae infections.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From hospital admission to hospital discharge (up to 60 days)
Secondary outcomes (10)
In-hospital Mortality Rate
Proportion of patients who died during the index hospitalization among patients with confirmed infection, assessed from medical records.
Measured: 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.
Measured: From hospital admission to hospital discharge (up to 60 days)
Macrolide Resistance Rate
Percentage of patients infected with a macrolide-resistant strain.
Measured: At time of microbiological diagnosis (baseline)
Need for invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation during hospitalization, assessed from medical records.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From hospital admission to hospital discharge (up to 60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start15 Sep 2024
- Primary completion15 Sep 2024
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479355
- Sponsor's protocol ID
- APHP240404
- Acronym
- ECRAN-PLASMA
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Characteristics of Acute Mycoplasma Resuscitation: ECRAN-PLASMA Study
- ClinicalTrials.gov ID
- NCT07479355
- Acronym / sponsor ID
- ECRAN-PLASMA / APHP240404
- Conditions
- Pneumonia
- Keywords
- Intensive Care Unit (ICU), Intensive Respiratory Care Unit (USIP), Intermediate Care Unit (USC), Chlamydia pneumoniae, Mycoplasma pneumoniae, Infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infectious disease epidemiologyevaluation of patient management, prognosis, and macrolide resistance rates in severe Mycoplasma pneumoniae and Chlamydia pneumoniae infections. | Other | – |
Primary outcome
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.
10 secondary outcomes
In-hospital Mortality Rate
Time frame: From hospital admission to hospital discharge (up to 60 days)
Length of Stay in ICU and Hospital
Time frame: From hospital admission to hospital discharge (up to 60 days)
Macrolide Resistance Rate
Time frame: At time of microbiological diagnosis (baseline)
Need for invasive mechanical ventilation
Time frame: From hospital admission to hospital discharge (up to 60 days)
Use of respiratory and supportive therapies
Time frame: From hospital admission to hospital discharge (up to 60 days)
Time from Symptom Onset to ICU Admission
Time frame: At patient admission.
In-hospital mortality compared with other bacterial pneumonias
Time frame: From hospital admission to hospital discharge (up to 60 days)
Vital status at hospital discharge
Time frame: During hospitalization (up to 60 days)
Respiratory support at hospital discharge
Time frame: During hospitalization (up to 60 days)
Occurrence of acute respiratory distress syndrome (ARDS)
Time frame: From hospital admission to hospital discharge (up to 60 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Severe Mycoplasma pneumoniae and Chlamydia pneumoniae Infections (time frame: From hospital admission to hospital discharge (up to 60 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.