Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR
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.
Community-Acquired Pneumonia (CAP)
|Study Design:||Time Perspective: Prospective|
|Official Title:||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|
- Disappearance or Significant Alleviation of Symptoms [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
- Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) [ Time Frame: Day 0, Day 8 - 16 ] [ Designated as safety issue: No ]Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).
- Body Temperature [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
- Bacteriological Investigation (if Available) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
- Cough and Its Character [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
- Dyspnea and Its Type [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
- Auscultation [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
- Chest X-ray in Case of Community-Acquired Pneumonia (CAP) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
- Study Drug Given as the First, Second or Third Antimicrobial Treatment [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
- Compliance [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
- Termination of Treatment Due to Noncompliance [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
|Study Start Date:||February 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130883
Show 135 Study Locations
|Study Director:||Adam Hloska, M.D.||Abbott Laboratories, s.r.o. (Czech Republic)|