A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP)
Overview
- Phase
- Phase 2
- Intervention
- Chest X-ray
- Conditions
- Community Acquired Pneumonia
- Sponsor
- Versailles Hospital
- Enrollment
- 310
- Locations
- 20
- Primary Endpoint
- clinical evaluation at Day 15
- Last Updated
- 8 years ago
Overview
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).
Investigators
Anne-claude Cremieux
Clinical Coordinator
Versailles Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Amoxicillin/Clavulanic acid treatment
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
Intervention: Chest X-ray
Amoxicillin/Clavulanic acid treatment
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
Intervention: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Amoxicillin/Clavulanic acid treatment
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
Intervention: Augmentin
Amoxicillin/Clavulanic acid treatment
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
Intervention: Beta-Lactams
placebo treatment
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
Intervention: Chest X-ray
placebo treatment
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
Intervention: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
placebo treatment
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
Intervention: Placebo (for Augmentin)
placebo treatment
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
Intervention: Beta-Lactams
Outcomes
Primary Outcomes
clinical evaluation at Day 15
Time Frame: 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 Outcomes
- clinical evaluation at Day 30(Day 30)