Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

Abbott

Status: Completed

Conditions: Chronic Bronchitis; Tracheobronchitis; Community-acquired Pneumonia; Tracheitis; Bronchitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01108185

P12-060

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 3,181 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men, women at least 18 years old

  • with acute tracheitis,
  • acute tracheobronchitis,
  • acute bronchitis,
  • mild community-acquired pneumonia or
  • acute exacerbation of chronic bronchitis

Exclusion criteria

• 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

Trial design

3,181 participants in 1 patient group

Acute Respiratory Infections

Description:

Slovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).