Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis or Mild Community-acquired Bronchopneumonia in Common Clinical Practice in the Slovak Republic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 3,181
- 试验地点
- 158
- 主要终点
- Compliance (Was the Dosage Followed - Yes, no)
研究概览
简要总结
The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).
详细描述
This PMOS will be conducted in a prospective, open-label, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with lower respiratory tract infection, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a PMOS, Klacid®SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.
Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Men, women at least 18 years old
- •with acute tracheitis,
- •acute tracheobronchitis,
- •acute bronchitis,
- •mild community-acquired pneumonia or
- •acute exacerbation of chronic bronchitis
排除标准
- •Patients with known hypersensitivity to macrolide antibiotics
- •Patients with documented renal impairment (creatinine clearance under 30 ml/min).
- •Patients with documented liver parenchyma impairment (AST, ALT and GMT > 3x higher level in comparison with the norm)
- •Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine
- •Pregnancy
- •Breast feeding
结局指标
主要结局
Compliance (Was the Dosage Followed - Yes, no)
时间窗: Day 10 - 16
Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events
时间窗: Day 0 through Days 10 - 16
The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.
次要结局
- Body Temperature(Day 10 - 16)
- Cough and Its Character(Day 10 - 16)
- Dyspnoea(Day 10 - 16)
- Auscultation(Day 10 - 16)