Definition of Sub-phenotypes of Pneumonia Based on the Respiratory Microbiome Composition to Predict Microbial and Clinical Treatment Failures

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 1, 2025

Keywords

ClinConnect Summary

The PHENOMENON study is a clinical trial aimed at understanding how the germs in our respiratory system (known as the respiratory microbiome) might influence the effectiveness of treatments for pneumonia. Pneumonia can be acquired in the community or in hospitals and is often treated with antibiotics. Unfortunately, some patients do not get better, which can lead to complications and increased resistance to antibiotics. This study will look at 300 adults with pneumonia in different hospital settings to see if the makeup of their respiratory microbiome can help predict how well they respond to antibiotics and whether they might face treatment failures.

To participate, individuals must be at least 18 years old and have symptoms of pneumonia, such as a cough, fever, and new lung issues visible on scans. They should also have started treatment for pneumonia within the last 24 hours. Participants will provide samples from their throat and rectum, as well as blood, at various points during their hospital stay. This research is important because it may lead to more personalized and effective treatment plans for pneumonia, ultimately helping to reduce the number of patients who don't respond to treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Cohort 1: CAP at emergency department and requiring hospitalization in general wards :
• • Age ≥18 years
• • Hospitalization in a medical department (not ICU)
• • Presence of at least one acute clinical sign compatible with pneumonia (e.g. dyspnea, cough, purulent sputum or purulent tracheal aspirations or crackles), and temperature above 38°C in the 48 hours prior to inclusion
• • AND new pulmonary infiltrate on chest X-ray or CT scan (on Day 0 or within three days of inclusion)
• • Efficient treatment initiated for less than 24 hours
• • Sputum collection possible
• * Cohort 2: Severe CAP with ICU hospitalization :
• • Age ≥18 years
• • Hospitalization in intensive care unit for at least 24 hours.
• • Presence of at least one acute clinical sign compatible with pneumonia (e.g. dyspnoea, cough, purulent sputum or crackles), temperature greater than 38°C in the 48 hours prior to hospital admission
• • AND new pulmonary infiltrate on chest X-ray or CT scan (on Day 0 or within three days of inclusion)
• • Efficient treatment initiated for less than 24 hours
• • Sputum collection or tracheal aspiration or any distal bacterial sample (BAL, plugged telescopic catheter) collection possible
• * Cohort 3: vHAP or VAP :
• • Age ≥18 years
• • vHAP: mechanical ventilation, in a patient previously hospitalized for more than 48 hours at the onset of new or worsening radiological infiltrates and 2 of the following: fever or hypothermia, leukocytosis \> 12 G/L or leukopenia \< 4G/L, purulent tracheal aspirates,
• • VAP: mechanical ventilation for more than 48 hours, new or worsening radiological infiltrates and 2 of the following: fever (\>38°C) or hypothermia (\<36.5°C) in the 24 hours prior to inclusion, leucocytosis\> 12 G/L or leukopenia \< 4G/L, purulent tracheal aspirates
• • AND plugged telescopic catheter (PTC) ≥103colony-forming units (CFU)/ml or bronchoalveolar lavage (BAL) culture ≥104 CFU/ml or purulent tracheal aspirates ≥ 106 UFC/mL
• • AND treated with active antibiotic therapy for pneumonia for less than 24 hours
• Exclusion Criteria:
• * Cohort 1: CAP with hospitalization in general wards :
• • AIDS
• • Patient on high-dose corticosteroids \>2 mg/kg prednisone equivalent
• • Bone marrow transplant patients
• • Cancer patients undergoing chemotherapy within 3 months of inclusion
• • Opposition of the patient (absence of informed written consent)
• • Scheduled transfer to another hospital
• • Patient under guardianship or comparable legal status
• • NB: Patients included in the cohort 1 and referred to ICU within the first 24 hours will be included in the cohort 2.
• * Cohort 2: Severe CAP with ICU hospitalization :
• • AIDS
• • Patient on high-dose corticosteroids \>2 mg/kg prednisone equivalent
• • Bone marrow transplant patients
• • Cancer patients undergoing chemotherapy within 3 months of inclusion
• • Stays shorter than 24h in the ICU will be exlcuded
• • Absence of informed written consent of the patient if they are fit, or absence of informed written consent of the relative/caregiver (for patients unable to understand the information and in the absence of a relative/caregiver, emergency inclusion is authorized)
• • Decision to forego life-sustaining therapy
• • Patient under guardianship or comparable legal status
• * Cohort 3: vHAP or VAP :
• • AIDS
• • Patient on high-dose corticosteroids \>2 mg/kg prednisone equivalent
• • Bone marrow transplant patients
• • Cancer patients undergoing chemotherapy within 3 months of inclusion
• • Absence of informed written consent of the patient if he is fit, or absence of informed written consent of the relative (for patients unable to understand the information and in the absence of a relative, emergency inclusion is authorized)
• • Decision to forego life-sustaining therapy
• • Patient under guardianship or comparable legal status