Personalized Antibiotic Treatment Duration for Adults Hospitalized with Moderate Community-Acquired Pneumonia
A Phase 3 Trial Comparing Customized and Standard Therapy Lengths
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-20
328
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to antibiotic treatment duration for patients hospitalized with moderately severe community-acquired pneumonia CAP. The study aims to determine if stopping antibiotics when specific stability criteria are met after at least 48 hours of treatment is as effective as the standard treatment duration. This phase III randomized trial also examines symptom evolution, quality of life, mortality, hospital stay length, adverse events, and antibiotic resistance.
Participants are randomly assigned to one of two groups one group receives antibiotic treatment determined by the physicians usual practice, typically lasting 5 to 10 days, while the other group stops antibiotic treatment once stability criteria are reached, but not before 48 hours. Stability criteria include normal body temperature, heart rate, blood pressure, oxygen saturation, respiratory rate, and mental status. The study does not involve a placebo and uses standard antibiotic treatments.
Participants will undergo evaluations of pneumonia symptoms and quality of life at multiple time points at treatment start Day 0, at stability Day S, and on Days 7, 15, and 30. Researchers will monitor the rate of cure at Day 15 primary outcome, as well as cure persistence, mortality, treatment duration, hospital stay length, adverse events, and antibiotic resistance genes up to Day 30. The total duration of participation depends on these assessments, with safety and treatment response closely observed throughout the study period.
CONDITIONS
Brief Title
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Research Team
A
Aurélien Dinh, MD, PhD
J
Jacques Ropers, PharmD
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Admitted to hospital for suspected community-acquired pneumonia with at least two of the following: fever above 38°C or hypothermia below 36°C, dyspnea, cough, production of purulent sputum, or crackles
Radiological evidence of new infiltrate on chest X-ray or CT scan
Negative viral respiratory testing
Treated with antibiotics for at least 48 hours (excluding azithromycin)
Presented early clinical response within the last 24 hours, including apyrexia (≤ 37.8°C), heart rate below 100/min, respiratory rate below 24/min, oxygen saturation at least 92%, and systolic blood pressure at least 90 mmHg
Antibiotic treatment started between 48 hours and 6 days ago
No other infection sites besides respiratory
Affiliated to health insurance
Provided informed consent
Understands oral and written French or has a relative to assist
You will not qualify if you...
Signs of severe community-acquired pneumonia such as abscess or massive pleural effusion
Known immunosuppression conditions including asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, or HIV with low CD4 count
Suspected or confirmed legionellosis
Any other infection requiring additional antibiotics
Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
Treatment with azithromycin
Concomitant steroid treatment for patients on fluoroquinolones
Pre-existing aortic aneurysm or dissection, related genetic disorders, uncontrolled hypertension, or atherosclerosis in patients on fluoroquinolones
Pregnant or breastfeeding women
Life expectancy less than one month
Under legal guardianship
Without fixed address
Enrolled in another interventional clinical trial on community-acquired pneumonia treatment
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - At least 48 hours up to 10 days depending on clinical response and physician's decision
Participants receive antibiotic treatment for community-acquired pneumonia, with duration customized based on clinical stability or physician judgment.
Visits at treatment initiation and as needed until treatment completion
Follow-up
Duration - Up to 30 days after treatment initiation
Participants are monitored for cure, symptom evolution, adverse events, and antibiotic resistance after treatment completion.
Visits at Day 7, Day 15, and Day 30
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial.