Overview

Short Duration Treatment of Non-severe Community Acquired Pneumonia

Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Versailles Hospital
Treatments:
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