NCT01095978

Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,822 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia. This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format. 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 with local guidelines.

Detailed description

The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period. The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Clarithromycin (Klacid SR)	Klacid SR in a dose of 1000 mg once daily

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-03-30
• Last updated: 2011-07-11
• Results posted: 2011-06-15

Locations

126 sites across 1 country: Ukraine