Community-acquired Pneumonia Clinical Trial
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
Verified date | September 2011 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Slovak Republic: Ethics Committee |
Study type | Observational |
The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR 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).
Status | Completed |
Enrollment | 3181 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Men, women at least 18 years old - with acute tracheitis, - acute tracheobronchitis, - acute bronchitis, - mild community-acquired pneumonia or - acute exacerbation of chronic bronchitis Exclusion Criteria: - Patients with known hypersensitivity to macrolide antibiotics - Patients with documented renal impairment (creatinine clearance under 30 ml/min). - Patients with documented liver parenchyma impairment (AST, ALT and GMT > 3x higher level in comparison with the norm) - Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine - Pregnancy - Breast feeding |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovakia | Site Reference ID/Investigator# 37753 | Banska Bystrica | |
Slovakia | Site Reference ID/Investigator# 37758 | Banska Bystrica | |
Slovakia | Site Reference ID/Investigator# 37806 | Bardejov | |
Slovakia | Site Reference ID/Investigator# 38052 | Bojnice | |
Slovakia | Site Reference ID/Investigator# 25682 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37677 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37678 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37679 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37680 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37681 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37729 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37732 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37823 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37824 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37825 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37826 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37827 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37828 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37829 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37830 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37831 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37832 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37833 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37834 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37835 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37836 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37837 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37838 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37839 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37840 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37861 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37864 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37866 | Bratislava | |
Slovakia | Site Reference ID/Investigator# 37754 | Brezno | |
Slovakia | Site Reference ID/Investigator# 37755 | Brezno | |
Slovakia | Site Reference ID/Investigator# 37756 | Brezno | |
Slovakia | Site Reference ID/Investigator# 37863 | Dojc | |
Slovakia | Site Reference ID/Investigator# 38048 | Dolne Vestenice | |
Slovakia | Site Reference ID/Investigator# 37694 | Dolny Kubin | |
Slovakia | Site Reference ID/Investigator# 38029 | Drienov | |
Slovakia | Site Reference ID/Investigator# 38056 | Dudince | |
Slovakia | Site Reference ID/Investigator# 37688 | Galanta | |
Slovakia | Site Reference ID/Investigator# 37703 | Galanta | |
Slovakia | Site Reference ID/Investigator# 37808 | Giraltovce | |
Slovakia | Site Reference ID/Investigator# 37708 | Horka nad Vahom | |
Slovakia | Site Reference ID/Investigator# 38054 | Hronske Klacany | |
Slovakia | Site Reference ID/Investigator# 37745 | Humenne | |
Slovakia | Site Reference ID/Investigator# 37752 | Humenne | |
Slovakia | Site Reference ID/Investigator# 37814 | Humenne | |
Slovakia | Site Reference ID/Investigator# 37815 | Humenne | |
Slovakia | Site Reference ID/Investigator# 37687 | Jelka | |
Slovakia | Site Reference ID/Investigator# 37737 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37740 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37741 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37742 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37744 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37767 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37788 | Kosice | |
Slovakia | Site Reference ID/Investigator# 38030 | Kosice | |
Slovakia | Site Reference ID/Investigator# 38035 | Kosice | |
Slovakia | Site Reference ID/Investigator# 38040 | Kosice | |
Slovakia | Site Reference ID/Investigator# 38043 | Kosice | |
Slovakia | Site Reference ID/Investigator# 37810 | Levoca | |
Slovakia | Site Reference ID/Investigator# 37811 | Levoca | |
Slovakia | Site Reference ID/Investigator# 37686 | Likavka | |
Slovakia | Site Reference ID/Investigator# 37690 | Lubochna | |
Slovakia | Site Reference ID/Investigator# 37790 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37791 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37792 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37793 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37795 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37797 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37798 | Lucenec | |
Slovakia | Site Reference ID/Investigator# 37859 | Malacky | |
Slovakia | Site Reference ID/Investigator# 37865 | Malacky | |
Slovakia | Site Reference ID/Investigator# 37696 | Martin | |
Slovakia | Site Reference ID/Investigator# 37702 | Martin | |
Slovakia | Site Reference ID/Investigator# 37706 | Martin | |
Slovakia | Site Reference ID/Investigator# 37743 | Michalovce | |
Slovakia | Site Reference ID/Investigator# 37766 | Michalovce | |
Slovakia | Site Reference ID/Investigator# 38028 | Michalovce | |
Slovakia | Site Reference ID/Investigator# 37862 | Modra | |
Slovakia | Site Reference ID/Investigator# 38042 | Moldava nad Bodvou | |
Slovakia | Site Reference ID/Investigator# 37697 | Namestovo | |
Slovakia | Site Reference ID/Investigator# 38036 | Nitra | |
Slovakia | Site Reference ID/Investigator# 38038 | Nitra | |
Slovakia | Site Reference ID/Investigator# 38039 | Nitra | |
Slovakia | Site Reference ID/Investigator# 38041 | Nitra | |
Slovakia | Site Reference ID/Investigator# 38050 | Nitra | |
Slovakia | Site Reference ID/Investigator# 38053 | Nitra | |
Slovakia | Site Reference ID/Investigator# 37692 | Nitrianske Pravno | |
Slovakia | Site Reference ID/Investigator# 38047 | Nitrianske Rudno | |
Slovakia | Site Reference ID/Investigator# 38045 | Novaky | |
Slovakia | Site Reference ID/Investigator# 38049 | Oslany | |
Slovakia | Site Reference ID/Investigator# 38051 | Partizanske | |
Slovakia | Site Reference ID/Investigator# 37731 | Piestany | |
Slovakia | Site Reference ID/Investigator# 37858 | Piestany | |
Slovakia | Site Reference ID/Investigator# 37812 | Podhradie | |
Slovakia | Site Reference ID/Investigator# 37757 | Pohorelska Masa | |
Slovakia | Site Reference ID/Investigator# 37804 | Presov | |
Slovakia | Site Reference ID/Investigator# 37809 | Presov | |
Slovakia | Site Reference ID/Investigator# 37817 | Presov | |
Slovakia | Site Reference ID/Investigator# 37789 | Revuca | |
Slovakia | Site Reference ID/Investigator# 37799 | Revuca | |
Slovakia | Site Reference ID/Investigator# 37762 | Rimavska Sobota | |
Slovakia | Site Reference ID/Investigator# 37763 | Rimavska Sobota | |
Slovakia | Site Reference ID/Investigator# 37764 | Rimavska Sobota | |
Slovakia | Site Reference ID/Investigator# 37765 | Rimavska Sobota | |
Slovakia | Site Reference ID/Investigator# 37800 | Roznava | |
Slovakia | Site Reference ID/Investigator# 37801 | Roznava | |
Slovakia | Site Reference ID/Investigator# 37693 | Ruzomberok | |
Slovakia | Site Reference ID/Investigator# 37698 | Ruzomberok | |
Slovakia | Site Reference ID/Investigator# 37685 | Samorin | |
Slovakia | Site Reference ID/Investigator# 37735 | Selice | |
Slovakia | Site Reference ID/Investigator# 37733 | Senec | |
Slovakia | Site Reference ID/Investigator# 37730 | Senica | |
Slovakia | Site Reference ID/Investigator# 38055 | Slatina nad Bebravou | |
Slovakia | Site Reference ID/Investigator# 37805 | Slovinky | |
Slovakia | Site Reference ID/Investigator# 38033 | Snina | |
Slovakia | Site Reference ID/Investigator# 38034 | Snina | |
Slovakia | Site Reference ID/Investigator# 38037 | Snina | |
Slovakia | Site Reference ID/Investigator# 37746 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37747 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37748 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37750 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37751 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37813 | Spisska Nova Ves | |
Slovakia | Site Reference ID/Investigator# 37736 | Streda nad Bodrogom | |
Slovakia | Site Reference ID/Investigator# 38031 | Streda nad Bodrogom | |
Slovakia | Site Reference ID/Investigator# 37860 | Stupava | |
Slovakia | Site Reference ID/Investigator# 37816 | Svidnik | |
Slovakia | Site Reference ID/Investigator# 38046 | Topolcany | |
Slovakia | Site Reference ID/Investigator# 37699 | Trencin | |
Slovakia | Site Reference ID/Investigator# 37734 | Trencin | |
Slovakia | Site Reference ID/Investigator# 37682 | Trhova Hradska | |
Slovakia | Site Reference ID/Investigator# 37683 | Trhova Hradska | |
Slovakia | Site Reference ID/Investigator# 37691 | Trnava | |
Slovakia | Site Reference ID/Investigator# 37705 | Trnava | |
Slovakia | Site Reference ID/Investigator# 37870 | Trnava | |
Slovakia | Site Reference ID/Investigator# 37701 | Trnovec nad Vahom | |
Slovakia | Site Reference ID/Investigator# 37695 | Turany | |
Slovakia | Site Reference ID/Investigator# 38032 | Velke Kapusany | |
Slovakia | Site Reference ID/Investigator# 37868 | Velke Kostolany | |
Slovakia | Site Reference ID/Investigator# 37760 | Velky Krtis | |
Slovakia | Site Reference ID/Investigator# 37761 | Velky Krtis | |
Slovakia | Site Reference ID/Investigator# 37807 | Vranov nad Toplou | |
Slovakia | Site Reference ID/Investigator# 37867 | Vrbove | |
Slovakia | Site Reference ID/Investigator# 37684 | Vrutky | |
Slovakia | Site Reference ID/Investigator# 38044 | Zabokreky nad Nitrou | |
Slovakia | Site Reference ID/Investigator# 37689 | Zilina | |
Slovakia | Site Reference ID/Investigator# 37700 | Zilina | |
Slovakia | Site Reference ID/Investigator# 37704 | Zilina | |
Slovakia | Site Reference ID/Investigator# 37707 | Zilina | |
Slovakia | Site Reference ID/Investigator# 37869 | Zohor | |
Slovakia | Site Reference ID/Investigator# 37794 | Zvolen | |
Slovakia | Site Reference ID/Investigator# 37796 | Zvolen | |
Slovakia | Site Reference ID/Investigator# 37802 | Zvolen | |
Slovakia | Site Reference ID/Investigator# 37803 | Zvolen |
Lead Sponsor | Collaborator |
---|---|
Abbott |
Slovakia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compliance (Was the Dosage Followed - Yes, no) | Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported. | Day 10 - 16 | No |
Primary | The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events | The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details. | Day 0 through Days 10 - 16 | No |
Secondary | Body Temperature | Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized. | Day 0 | No |
Secondary | Body Temperature | Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized. | Day 10 - 16 | No |
Secondary | Cough and Its Character | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented. | Day 0 | No |
Secondary | Cough and Its Character | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented. | Day 10 - 16 | No |
Secondary | Dyspnoea | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented. | Day 0 | No |
Secondary | Dyspnoea | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented. | Day 10 - 16 | No |
Secondary | Auscultation | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized. | Day 0 | No |
Secondary | Auscultation | Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized. | Day 10 - 16 | No |
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