NCT01130883

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,130 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, 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 acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, 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. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

Detailed description

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Conditions

• Tracheitis
• Tracheobronchitis
• Bronchitis
• Chronic Bronchitis
• Community-Acquired Pneumonia (CAP)

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-05-26
• Last updated: 2025-10-06
• Results posted: 2011-08-23

Locations

135 sites across 1 country: Czechia