Actively Recruiting
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-20
328
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting. As the secondary objectives, the study aims * To study if the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of: * Persistence of cure at Day 30 of antibiotic treatment * All-cause mortality rate on Day 30 of antibiotic treatment * Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment. * To compare between the 2 study arms at Day 30 of antibiotic treatment: * The duration of antibiotic treatment; * The length of hospital stay; * The frequency and severity of adverse events during the 30 days after the start of treatment. * To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.
CONDITIONS
Official Title
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (18 years old or older)
- Hospitalized for suspected community-acquired pneumonia with at least two of: fever (>38°C) or hypothermia (<36°C), dyspnea, cough, purulent sputum, or crackles
- Radiological evidence of new lung infiltrate by chest X-ray or CT scan
- Negative viral respiratory test
- Treated with antibiotics (excluding azithromycin) for at least 48 hours
- Early clinical response within last 24 hours (apyrexia ≤37.8°C, heart rate <100/min, respiratory rate <24/min, oxygen saturation ≥92%, systolic blood pressure ≥90 mmHg)
- Antibiotic treatment started between 48 hours and 6 days ago
- No infection outside the respiratory tract
- 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 (abscess, massive pleural effusion, severe chronic respiratory insufficiency)
- Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, HIV with CD4 <200/mm3)
- Suspected or confirmed legionellosis
- Other infections requiring antibiotics
- Confirmed or suspected aspiration or healthcare-associated pneumonia
- Use of azithromycin for suspected CAP
- Concomitant steroid treatment if receiving fluoroquinolones
- Pre-existing aortic aneurysm or related conditions if receiving fluoroquinolones
- Pregnant or breastfeeding women
- Life expectancy less than 1 month
- Under legal guardianship
- Without fixed address
- Enrolled in another interventional CAP clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Infectious diseases department, Raymond-Poincaré Hospital - APHP
Garches, France, 92380
Actively Recruiting
Research Team
A
Aurélien Dinh, MD, PhD
CONTACT
J
Jacques Ropers, PharmD
CONTACT
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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