Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01130883|
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : August 23, 2011
Last Update Posted : September 12, 2011
|Condition or disease|
|Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-Acquired Pneumonia (CAP)|
|Study Type :||Observational|
|Actual Enrollment :||3130 participants|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||July 2010|
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).
- Disappearance or Significant Alleviation of Symptoms [ Time Frame: Day 8 - 16 ]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 ]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 ]Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
- Bacteriological Investigation (if Available) [ Time Frame: Day 0 ]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 ]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 ]Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
- Auscultation [ Time Frame: Day 0, Day 8-16 ]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 ]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 ]Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
- Compliance [ Time Frame: Day 8 - 16 ]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 ]Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130883
|Study Director:||Adam Hloska, M.D.||Abbott Laboratories, s.r.o. (Czech Republic)|