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)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 310
- 试验地点
- 20
- 主要终点
- clinical evaluation at Day 15
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Amoxicillin/Clavulanic acid treatment
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
干预措施: Chest X-ray (Radiation)
Amoxicillin/Clavulanic acid treatment
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
干预措施: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry (Biological)
Amoxicillin/Clavulanic acid treatment
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
干预措施: Augmentin (Drug)
Amoxicillin/Clavulanic acid treatment
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
干预措施: Beta-Lactams (Drug)
placebo treatment
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
干预措施: Chest X-ray (Radiation)
placebo treatment
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
干预措施: blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry (Biological)
placebo treatment
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
干预措施: Placebo (for Augmentin) (Drug)
placebo treatment
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
干预措施: Beta-Lactams (Drug)
结局指标
主要结局
clinical evaluation at Day 15
时间窗: Day 15
Clinical evaluation at Day 15 composed of the composite measure of the Clinical examination for clinical symptoms of CAP, recording of the body temperature and confirmation that no additionnal antibiotic treatment was required from Day 8
次要结局
- clinical evaluation at Day 30(Day 30)
研究者
Anne-claude Cremieux
Clinical Coordinator
Versailles Hospital