Ignite Creation Date:
2024-05-05 @ 10:33 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01130883
Status:
COMPLETED
Last Update Posted:
2011-09-12
First Post:
2010-05-06
Brief Title:
Evaluation of Effectiveness of the Treatment After Repeated Administration of KlacidSR
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
Evaluation of Effectiveness of the Treatment After Repeated Administration of KlacidSR 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
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:
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
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