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| Sponsor: | Abbott |
|---|---|
| Information provided by (Responsible Party): | Abbott |
| ClinicalTrials.gov Identifier: | NCT01108185 |
Purpose
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).
| Condition |
|---|
|
Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-acquired Pneumonia |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
| Enrollment: | 3181 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Acute Respiratory Infections
Slovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients included in this PMOS will be those with acute tracheitis, acute tracheobronchitis, acute bronchitis, mild CAP and acute exacerbation of chronic bronchitis with infectious etiology caused probably by an atypical agent.
Inclusion Criteria:
Men, women at least 18 years old
Exclusion Criteria:
Contacts and Locations
Show 158 Study Locations| Study Director: | Adam Hloska, M.D. | Abbott |
More Information
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01108185 History of Changes |
| Other Study ID Numbers: | P12-060 |
| Study First Received: | April 20, 2010 |
| Results First Received: | July 26, 2011 |
| Last Updated: | September 9, 2011 |
| Health Authority: | Slovak Republic: Ethics Committee |
|
treatment with Klacid®SR tracheitis tracheobronchitis |
bronchitis chronic bronchitis community-acquired pneumonia |
|
Bronchitis Acute Disease Bronchitis, Chronic Pneumonia Respiratory Tract Infections Tracheitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Disease Attributes Pathologic Processes Pulmonary Disease, Chronic Obstructive Infection Tracheal Diseases |