Informations générales (source: ClinicalTrials.gov)
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) (PTC)
Interventional
Phase 2
Versailles Hospital (Voir sur ClinicalTrials)
novembre 2013
juin 2018
29 juin 2024
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).
Etablissements
Critères
Tous
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.
- 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