Status:
RECRUITING
Definition of Sub-phenotypes of Pneumonia Based on the Respiratory Microbiome Composition to Predict Microbial and Clinical Treatment Failures
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Community Acquired or Acquiring Hospital Acquired Pneumonia
Eligibility:
All Genders
18+ years
Brief Summary
Background: Pneumonia remains a leading cause of antibiotic consumption globally, contributing significantly to the burden of antimicrobial resistance (AMR). The respiratory microbiome plays a crucial...
Detailed Description
Pneumonia can be acquired in the community such as COVID-19 or flu, or during hospitalization for a different medical condition. The significant burden of CAP is set to increase with ageing populatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06916481
Start Date
November 6 2025
End Date
September 15 2028
Last Update
November 24 2025
Active Locations (6)
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1
Hospital Beaujon
Clichy, France
2
CHU Nantes - Saint Herblain
Nantes, France
3
CHU Nantes - Saint Herblain
Nantes, France
4
CHU Nantes
Nantes, France