Ignite Creation Date:
2024-05-05 @ 10:24 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01108185
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2010-04-20
Brief Title:
Evaluation of the Treatment With KlacidSR in Patients With Lower Respiratory Tract Infection
Sponsor:
Abbott
Organization:
Abbott
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this post-marketing observational study PMOS is to describe the relief of symptoms tolerability and compliance of treatment with KlacidSR 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
Detailed 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 KlacidSR 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 KlacidSR would be taken prior to entry of a subject in the study
Follow-up of patients should enable two patient visits during this period ScreeningInclusion Visit will be performed when the decision to start the treatment with KlacidSR is made Inclusion of patient in the study will succeed at day 0 SI Visit The Second Visit will follow 10 - 16 days after the ScreeningInclusion Visit
Follow-up of patients should enable two patient visits during this period ScreeningInclusion Visit will be performed when the decision to start the treatment with KlacidSR is made Inclusion of patient in the study will succeed at day 0 SI Visit The Second Visit will follow 10 - 16 days after the ScreeningInclusion Visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None