Community Acquired Pneumonia
Conditions
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).
Interventions
RADIATIONChest X-ray
at Day 0, Day 30 and relapse
BIOLOGICALblood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
DRUGAugmentin
2 tablets 3 times a day for 5 days from Day 3
DRUGPlacebo (for Augmentin)
2 tablets 3 times a day for 5 days from Day 3
DRUGBeta-Lactams
administered from Day 0 to Day 3
Sponsors
Versailles Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame |
|---|---|
| mortality all causes at Day 30 | Day 30 |
Countries
France
Contacts
Primary ContactAnne-Claude CREMIEUX, PH
Backup ContactAurélien DINH, Dr
Outcome results
None listed