Trial | NCT01963442  Report issue

Title

Short Duration Treatment of Non-severe Community Acquired Pneumonia
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)

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    clavulanate ...

  • Study Participants

    310
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).
Study Started
Nov 30
2013
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Jun 30
2018
Anticipated
Last Update
Aug 14
2017

Radiation Chest X-ray

at Day 0, Day 30 and relapse

Biological blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry

Drug Augmentin

2 tablets 3 times a day for 5 days from Day 3

Drug Placebo (for Augmentin)

2 tablets 3 times a day for 5 days from Day 3

Drug Beta-Lactams

administered from Day 0 to Day 3

Amoxicillin/Clavulanic acid treatment Active Comparator

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

placebo treatment Placebo Comparator

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

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
No Results Posted