Actively Recruiting
Definition of Sub-phenotypes of Pneumonia Based on the Respiratory Microbiome Composition to Predict Microbial and Clinical Treatment Failures
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-24
300
Participants Needed
6
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 role in the emergence of AMR and therapeutic failure in both community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP). The PHENOMENON study aims to investigate the relationship between the respiratory microbiome composition and clinical outcomes to improve the prediction of treatment failure and AMR emergence. Methods: This multicenter prospective cohort study will include 300 adult patients across three cohorts: CAP in general wards, severe CAP in intensive care units (ICU), and ventilator-associated HAP (vHAP/VAP). Patients will undergo oropharyngeal and rectal swabbing at admission (Day 0), Day 3, Day 7-10, and Day 90, along with blood sampling and endotracheal aspirates in intubated patients. The primary objective is to assess the association between baseline respiratory microbiome composition and time to antibiotic response within 7-10 days. The composite primary endpoint includes clinical failure, microbiological failure, or AMR emergence. Secondary endpoints explore the association between microbiome composition and pneumonia recurrence, severity, hospital length of stay, and mortality at Day 28 and Day 90. Expected Outcomes: This study will provide insights into the predictive value of respiratory microbiome composition on antibiotic response and AMR emergence. Understanding these relationships may guide personalized antibiotic strategies and optimize pneumonia management, ultimately reducing treatment failure rates and improving patient outcomes.
CONDITIONS
Official Title
Definition of Sub-phenotypes of Pneumonia Based on the Respiratory Microbiome Composition to Predict Microbial and Clinical Treatment Failures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Hospitalized with community-acquired pneumonia in a general ward (not ICU) with at least one acute clinical sign (e.g., dyspnea, cough, purulent sputum, crackles) and a fever above 386C in the past 48 hours
- New pulmonary infiltrate seen on chest X-ray or CT scan within three days of inclusion
- Antibiotic treatment started less than 24 hours before inclusion
- Sputum collection possible
- Hospitalized in intensive care unit for severe community-acquired pneumonia for at least 24 hours
- Presence of at least one acute clinical sign compatible with pneumonia and fever above 386C in the 48 hours prior to admission
- New pulmonary infiltrate on chest X-ray or CT scan within three days of inclusion
- Sputum, tracheal aspiration, or other bacterial sample collection possible
- Age 18 years or older
- Ventilator-associated hospital-acquired pneumonia with mechanical ventilation for more than 48 hours, new or worsening infiltrates, and specified clinical signs (fever/hypothermia, leukocytosis/leukopenia, purulent tracheal aspirates)
- Treated with active antibiotic therapy for pneumonia for less than 24 hours
- Relevant bacterial culture thresholds met for bronchial samples
You will not qualify if you...
- Diagnosis of AIDS
- Use of high-dose corticosteroids (>2 mg/kg prednisone equivalent)
- Bone marrow transplant recipients
- Cancer patients undergoing chemotherapy within 3 months prior to inclusion
- Refusal or absence of informed written consent
- Scheduled transfer to another hospital
- Patient under guardianship or similar legal status
- ICU stay less than 24 hours for severe CAP cohort
- Decision to forego life-sustaining therapy
- Emergency inclusion authorized only if consent unavailable and no caregiver present
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Beaujon
Clichy, France
Active, Not Recruiting
2
CHU Nantes - Saint Herblain
Nantes, France
Not Yet Recruiting
3
CHU Nantes - Saint Herblain
Nantes, France
Not Yet Recruiting
4
CHU Nantes
Nantes, France
Active, Not Recruiting
5
Hospital Bichat
Paris, France, 75 018
Actively Recruiting
6
Hospital Bichat
Paris, France
Active, Not Recruiting
Research Team
J
Jean-françois TIMSIT, MD, PHD
CONTACT
A
Antoine Roquilly, MD, PHD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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