Overview
Short Duration Treatment of Non-severe Community Acquired Pneumonia
Status:
Unknown status
Unknown status
Trial end date:
2018-06-01
2018-06-01
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Versailles HospitalTreatments:
Amoxicillin-Potassium Clavulanate Combination
beta-Lactams
Clavulanic Acid
Clavulanic Acids
Lactams
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.
- 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