Short Duration Treatment of Non-severe Community Acquired Pneumonia
- Conditions
- Community Acquired Pneumonia
- Interventions
- Radiation: Chest X-rayBiological: blood sampling /Cell Counts/ C reactive protein (CRP)/BiochemistryDrug: Placebo (for Augmentin)Drug: Beta-Lactams
- Registration Number
- NCT01963442
- Lead Sponsor
- Versailles Hospital
- Brief Summary
To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 310
- Subject must be 18 years old or over.
- admitted three days before for Community Acquired Pneumonia (CAP) defined by at least one clinical sign of pneumonia (dyspnea, cough, mucopurulent sputum, crackling sound on lungs) associated with a temperature >38°C on admission, and a new infiltrate consistent with pneumonia on chest x-ray, who responded favorably to 3 days of treatment with β-lactams (third generation injectable cephalosporin or amoxicillin-clavulanate)
- able to take oral medication.
- has given its informed consent.
- Creatinin < 30ml/min
- History of jaundice / hepatic impairment associated with amoxicillin / clavulanic acid
- History of hypersensitivity to beta-lactam
- Presence of complications or severity of pneumonia (abscess , significant pleural effusion, severe chronic respiratory failure , septic shock, respiratory condition requiring the passage resuscitation).
- Known immunocompromised terrain ( asplenia , neutropenia, agammaglobulinemia , immunosuppressants, graft corticosteroids , myeloma , lymphoma, known HIV , sickle cell anemia , CHILD C cirrhosis).
- Antibiotic treatment exceeding 24 hours prior admission.
- Suspected atypical bacteria requiring combined antibiotics therapy .(Subjects who received a single dose of macrolides or fluoroquinolones emergency will not be excluded) .
- Legionella suspected on clinical, biological and radiological criteria .
- Subjects with clinical or epidemiological environment leading to suspect a healthcare-associated pneumonia with antibiotic resistant pathogen.
- Suspicion of pneumonia by aspiration.
- Intercurrent infection requiring antibiotic treatment.
- Pregnant women .
- Breastfeeding .
- Allergy to antibiotics in use.
- Life expectancy <1 month .
- Subject without health insurance.
- Subjects without home adress
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amoxicillin/Clavulanic acid treatment Chest X-ray after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse Amoxicillin/Clavulanic acid treatment blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse Amoxicillin/Clavulanic acid treatment Augmentin after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse Amoxicillin/Clavulanic acid treatment Beta-Lactams after 3 day treatment of β-lactams, the subjects receive 5-day treatment of Amoxicillin/clavulanic acid. Chest X-ray performed at admission and Day 30 and replapses. 'blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse placebo treatment Chest X-ray after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse placebo treatment blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse placebo treatment Placebo (for Augmentin) after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse placebo treatment Beta-Lactams after 3-day treatment of β-lactams, the subjects receive 5-day treatment of placebo. Chest X-ray performed at admission and Day 30 and replapse. blood sampling /Cell Counts/CRP/Biochemistry' performed at Day 0, Day 30 and relapse
- Primary Outcome Measures
Name Time Method clinical evaluation at Day 15 Day 15 Clinical evaluation at Day 15 composed of the composite measure of the Clinical examination for clinical symptoms of CAP, recording of the body temperature and confirmation that no additionnal antibiotic treatment was required from Day 8
- Secondary Outcome Measures
Name Time Method clinical evaluation at Day 30 Day 30 Clinical evaluation at Day 30 composed of the composite measure of the Clinical examination for clinical symptoms of CAP, recording of the body temperature and Evaluation of replapse or aggravation of pneumonia or any other respiratory infections in subjects considered cured at Day 15.
Trial Locations
- Locations (20)
Foch Hospital
🇫🇷Suresnes, France
CH Versailles
🇫🇷Le Chesnay, France
CHI Creteil
🇫🇷Creteil, France
CH Beaujon
🇫🇷Clichy, France
CHU Rennes Pontchaillou
🇫🇷Rennes, France
CHU Ambroise Paré
🇫🇷Boulogne-Billancourt, France
CH Argenteuil
🇫🇷Argenteuil, France
CH d'Annecy Genevois
🇫🇷Metz-Tessy, France
Central Hospital Raymon Poincaré
🇫🇷Garches, France
CH Bicêtre
🇫🇷Le Kremlin Bicètre, France
CHU de Grenoble
🇫🇷La Tronche, France
Melun Hospital
🇫🇷Melun, France
CH Lariboisière
🇫🇷Paris, France
CHU Saint Antoine
🇫🇷Paris, France
CHU Cochin
🇫🇷Paris, France
CHU Bichat
🇫🇷Paris, France
CH Tenon
🇫🇷Paris, France
CH Pontoise
🇫🇷Pontoise, France
CH Saint Denis
🇫🇷Saint Denis, France
CHU Rouen
🇫🇷Rouen, France