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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Site Reference ID/Investigator# 37381
Bílina, Czechia
Site Reference ID/Investigator# 37391
Bílina, Czechia
Site Reference ID/Investigator# 37282
Blansko, Czechia
Site Reference ID/Investigator# 37324
Blansko, Czechia
Site Reference ID/Investigator# 37424
Boskovice, Czechia
Site Reference ID/Investigator# 37329
Brandýs nad Labem, Czechia
Site Reference ID/Investigator# 37268
Brno, Czechia
Site Reference ID/Investigator# 37299
Brno, Czechia
Site Reference ID/Investigator# 37331
Brno, Czechia
Site Reference ID/Investigator# 37396
Brno, Czechia
Start Date
February 1, 2010
Primary Completion Date
July 1, 2010
Completion Date
July 1, 2010
Last Updated
October 6, 2025
3,130
ACTUAL participants
Lead Sponsor
Abbott
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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