Community Acquired Pneumonia | Short Duration Treatment of Non-severe Community Acquired Pneumonia
Community Acquired Pneumonia research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Community Acquired Pneumonia
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Radiation:Chest X-rayat Day 0, Day 30 and relapse
Biological:blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry
Drug:Augmentin2 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-Lactamsadministered from Day 0 to Day 3
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Amoxicillin/Clavulanic acid treatmentafter 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 treatmentafter 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
Start Date: November 2013
Completed Date: June 2018
Phase: Phase 2
Primary Outcome: clinical evaluation at Day 15
Secondary Outcome: clinical evaluation at Day 30
Study sponsors, principal investigator, and references
Principal Investigator: Anne-Claude CREMIEUX, Pr
Lead Sponsor: Versailles Hospital