Short Duration Treatment of Non-severe Community Acquired Pneumonia

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Community Acquired Pneumonia

Intervention / Treatment
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* Radiation: Chest X-ray
* Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
* Drug: Augmentin
* Drug: Placebo (for Augmentin)
* Drug: Beta-Lactams


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin/Clavulanic acid treatment<br>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 | Radiation: Chest X-ray<br>* at Day 0, Day 30 and relapse<br>Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry<br> <br> Drug: Augmentin<br>* 2 tablets 3 times a day for 5 days from Day 3<br>Drug: Beta-Lactams<br>* administered from Day 0 to Day 3<br>|
| Placebo Comparator: placebo treatment<br>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 | Radiation: Chest X-ray<br>* at Day 0, Day 30 and relapse<br>Biological: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry<br> <br> Drug: Placebo (for Augmentin)<br>* 2 tablets 3 times a day for 5 days from Day 3<br>Drug: Beta-Lactams<br>* administered from Day 0 to Day 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical evaluation at 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 | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical evaluation at 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. | Day 30 |