Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

September 9, 2011 updated by: Abbott

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

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).

Study Overview

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, 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. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.

Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.

Study Type

Observational

Enrollment (Actual)

3181

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Banska Bystrica, Slovakia, 97401
        • Site Reference ID/Investigator# 37753
      • Banska Bystrica, Slovakia, 97401
        • Site Reference ID/Investigator# 37758
      • Bardejov, Slovakia, 08501
        • Site Reference ID/Investigator# 37806
      • Bojnice, Slovakia, 97201
        • Site Reference ID/Investigator# 38052
      • Bratislava, Slovakia, 81107
        • Site Reference ID/Investigator# 37830
      • Bratislava, Slovakia, 81108
        • Site Reference ID/Investigator# 37828
      • Bratislava, Slovakia, 82007
        • Site Reference ID/Investigator# 37823
      • Bratislava, Slovakia, 82007
        • Site Reference ID/Investigator# 37824
      • Bratislava, Slovakia, 82007
        • Site Reference ID/Investigator# 37827
      • Bratislava, Slovakia, 82101
        • Site Reference ID/Investigator# 37826
      • Bratislava, Slovakia, 82103
        • Site Reference ID/Investigator# 37680
      • Bratislava, Slovakia, 82106
        • Site Reference ID/Investigator# 37681
      • Bratislava, Slovakia, 82106
        • Site Reference ID/Investigator# 37825
      • Bratislava, Slovakia, 82107
        • Site Reference ID/Investigator# 37829
      • Bratislava, Slovakia, 83101
        • Site Reference ID/Investigator# 37732
      • Bratislava, Slovakia, 83299
        • Site Reference ID/Investigator# 37831
      • Bratislava, Slovakia, 83299
        • Site Reference ID/Investigator# 37833
      • Bratislava, Slovakia, 83309
        • Site Reference ID/Investigator# 37729
      • Bratislava, Slovakia, 83309
        • Site Reference ID/Investigator# 37840
      • Bratislava, Slovakia, 84101
        • Site Reference ID/Investigator# 37679
      • Bratislava, Slovakia, 84102
        • Site Reference ID/Investigator# 37835
      • Bratislava, Slovakia, 84102
        • Site Reference ID/Investigator# 37839
      • Bratislava, Slovakia, 84104
        • Site Reference ID/Investigator# 37834
      • Bratislava, Slovakia, 84108
        • Site Reference ID/Investigator# 37832
      • Bratislava, Slovakia, 84231
        • Site Reference ID/Investigator# 37678
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37836
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37837
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37838
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37861
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37864
      • Bratislava, Slovakia, 85101
        • Site Reference ID/Investigator# 37866
      • Bratislava, Slovakia, 85104
        • Site Reference ID/Investigator# 25682
      • Bratislava, Slovakia, 85105
        • Site Reference ID/Investigator# 37677
      • Brezno, Slovakia, 97701
        • Site Reference ID/Investigator# 37754
      • Brezno, Slovakia, 97701
        • Site Reference ID/Investigator# 37755
      • Brezno, Slovakia, 97701
        • Site Reference ID/Investigator# 37756
      • Dojc, Slovakia, 90602
        • Site Reference ID/Investigator# 37863
      • Dolne Vestenice, Slovakia, 97223
        • Site Reference ID/Investigator# 38048
      • Dolny Kubin, Slovakia, 2601
        • Site Reference ID/Investigator# 37694
      • Drienov, Slovakia, 08024
        • Site Reference ID/Investigator# 38029
      • Dudince, Slovakia, 962 71
        • Site Reference ID/Investigator# 38056
      • Galanta, Slovakia, 92401
        • Site Reference ID/Investigator# 37688
      • Galanta, Slovakia, 92401
        • Site Reference ID/Investigator# 37703
      • Giraltovce, Slovakia, 08701
        • Site Reference ID/Investigator# 37808
      • Horka nad Vahom, Slovakia, 91632
        • Site Reference ID/Investigator# 37708
      • Hronske Klacany, Slovakia, 95329
        • Site Reference ID/Investigator# 38054
      • Humenne, Slovakia, 06601
        • Site Reference ID/Investigator# 37745
      • Humenne, Slovakia, 06601
        • Site Reference ID/Investigator# 37752
      • Humenne, Slovakia, 06601
        • Site Reference ID/Investigator# 37814
      • Humenne, Slovakia, 06601
        • Site Reference ID/Investigator# 37815
      • Jelka, Slovakia, 92523
        • Site Reference ID/Investigator# 37687
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37737
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37740
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37741
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37744
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37767
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 37788
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 38030
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 38035
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 38040
      • Kosice, Slovakia, 04001
        • Site Reference ID/Investigator# 38043
      • Kosice, Slovakia, 4001
        • Site Reference ID/Investigator# 37742
      • Levoca, Slovakia, 05401
        • Site Reference ID/Investigator# 37810
      • Levoca, Slovakia, 05401
        • Site Reference ID/Investigator# 37811
      • Likavka, Slovakia, 83495
        • Site Reference ID/Investigator# 37686
      • Lubochna, Slovakia, 3491
        • Site Reference ID/Investigator# 37690
      • Lucenec, Slovakia, 984 01
        • Site Reference ID/Investigator# 37790
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37791
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37792
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37793
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37795
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37797
      • Lucenec, Slovakia, 98401
        • Site Reference ID/Investigator# 37798
      • Malacky, Slovakia, 90101
        • Site Reference ID/Investigator# 37859
      • Malacky, Slovakia, 90101
        • Site Reference ID/Investigator# 37865
      • Martin, Slovakia, 3601
        • Site Reference ID/Investigator# 37696
      • Martin, Slovakia, 3601
        • Site Reference ID/Investigator# 37702
      • Martin, Slovakia, 3601
        • Site Reference ID/Investigator# 37706
      • Michalovce, Slovakia, 07101
        • Site Reference ID/Investigator# 37743
      • Michalovce, Slovakia, 07101
        • Site Reference ID/Investigator# 37766
      • Michalovce, Slovakia, 07101
        • Site Reference ID/Investigator# 38028
      • Modra, Slovakia, 90001
        • Site Reference ID/Investigator# 37862
      • Moldava nad Bodvou, Slovakia, 04501
        • Site Reference ID/Investigator# 38042
      • Namestovo, Slovakia, 2901
        • Site Reference ID/Investigator# 37697
      • Nitra, Slovakia, 94901
        • Site Reference ID/Investigator# 38041
      • Nitra, Slovakia, 94901
        • Site Reference ID/Investigator# 38050
      • Nitra, Slovakia, 94911
        • Site Reference ID/Investigator# 38053
      • Nitra, Slovakia, 94988
        • Site Reference ID/Investigator# 38036
      • Nitra, Slovakia, 94988
        • Site Reference ID/Investigator# 38038
      • Nitra, Slovakia, 94988
        • Site Reference ID/Investigator# 38039
      • Nitrianske Pravno, Slovakia, 3822
        • Site Reference ID/Investigator# 37692
      • Nitrianske Rudno, Slovakia, 97226
        • Site Reference ID/Investigator# 38047
      • Novaky, Slovakia, 97271
        • Site Reference ID/Investigator# 38045
      • Oslany, Slovakia, 97247
        • Site Reference ID/Investigator# 38049
      • Partizanske, Slovakia, 95801
        • Site Reference ID/Investigator# 38051
      • Piestany, Slovakia, 92101
        • Site Reference ID/Investigator# 37731
      • Piestany, Slovakia, 92101
        • Site Reference ID/Investigator# 37858
      • Podhradie, Slovakia, 05304
        • Site Reference ID/Investigator# 37812
      • Pohorelska Masa, Slovakia, 97669
        • Site Reference ID/Investigator# 37757
      • Presov, Slovakia, 08001
        • Site Reference ID/Investigator# 37804
      • Presov, Slovakia, 08001
        • Site Reference ID/Investigator# 37809
      • Presov, Slovakia, 08001
        • Site Reference ID/Investigator# 37817
      • Revuca, Slovakia, 05001
        • Site Reference ID/Investigator# 37789
      • Revuca, Slovakia, 05001
        • Site Reference ID/Investigator# 37799
      • Rimavska Sobota, Slovakia, 97901
        • Site Reference ID/Investigator# 37762
      • Rimavska Sobota, Slovakia, 97901
        • Site Reference ID/Investigator# 37763
      • Rimavska Sobota, Slovakia, 97901
        • Site Reference ID/Investigator# 37764
      • Rimavska Sobota, Slovakia, 97901
        • Site Reference ID/Investigator# 37765
      • Roznava, Slovakia, 04801
        • Site Reference ID/Investigator# 37800
      • Roznava, Slovakia, 04801
        • Site Reference ID/Investigator# 37801
      • Ruzomberok, Slovakia, 034 01
        • Site Reference ID/Investigator# 37698
      • Ruzomberok, Slovakia, 3401
        • Site Reference ID/Investigator# 37693
      • Samorin, Slovakia, 93101
        • Site Reference ID/Investigator# 37685
      • Selice, Slovakia, 92572
        • Site Reference ID/Investigator# 37735
      • Senec, Slovakia, 90301
        • Site Reference ID/Investigator# 37733
      • Senica, Slovakia, 90632
        • Site Reference ID/Investigator# 37730
      • Slatina nad Bebravou, Slovakia, 95653
        • Site Reference ID/Investigator# 38055
      • Slovinky, Slovakia, 05340
        • Site Reference ID/Investigator# 37805
      • Snina, Slovakia, 06901
        • Site Reference ID/Investigator# 38033
      • Snina, Slovakia, 06901
        • Site Reference ID/Investigator# 38034
      • Snina, Slovakia, 06901
        • Site Reference ID/Investigator# 38037
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37746
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37747
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37748
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37750
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37751
      • Spisska Nova Ves, Slovakia, 05201
        • Site Reference ID/Investigator# 37813
      • Streda nad Bodrogom, Slovakia, 07631
        • Site Reference ID/Investigator# 37736
      • Streda nad Bodrogom, Slovakia, 07631
        • Site Reference ID/Investigator# 38031
      • Stupava, Slovakia, 90101
        • Site Reference ID/Investigator# 37860
      • Svidnik, Slovakia, 08901
        • Site Reference ID/Investigator# 37816
      • Topolcany, Slovakia, 95501
        • Site Reference ID/Investigator# 38046
      • Trencin, Slovakia, 91101
        • Site Reference ID/Investigator# 37734
      • Trencin, Slovakia, 91105
        • Site Reference ID/Investigator# 37699
      • Trhova Hradska, Slovakia, 93013
        • Site Reference ID/Investigator# 37682
      • Trhova Hradska, Slovakia, 93013
        • Site Reference ID/Investigator# 37683
      • Trnava, Slovakia, 3901
        • Site Reference ID/Investigator# 37691
      • Trnava, Slovakia, 91701
        • Site Reference ID/Investigator# 37705
      • Trnava, Slovakia, 91701
        • Site Reference ID/Investigator# 37870
      • Trnovec nad Vahom, Slovakia, 92571
        • Site Reference ID/Investigator# 37701
      • Turany, Slovakia, 3853
        • Site Reference ID/Investigator# 37695
      • Velke Kapusany, Slovakia, 07901
        • Site Reference ID/Investigator# 38032
      • Velke Kostolany, Slovakia, 92207
        • Site Reference ID/Investigator# 37868
      • Velky Krtis, Slovakia, 99001
        • Site Reference ID/Investigator# 37760
      • Velky Krtis, Slovakia, 99001
        • Site Reference ID/Investigator# 37761
      • Vranov nad Topľou, Slovakia, 09301
        • Site Reference ID/Investigator# 37807
      • Vrbove, Slovakia, 92203
        • Site Reference ID/Investigator# 37867
      • Vrutky, Slovakia, 3861
        • Site Reference ID/Investigator# 37684
      • Zabokreky nad Nitrou, Slovakia, 95852
        • Site Reference ID/Investigator# 38044
      • Zilina, Slovakia, 1001
        • Site Reference ID/Investigator# 37689
      • Zilina, Slovakia, 1001
        • Site Reference ID/Investigator# 37700
      • Zilina, Slovakia, 1001
        • Site Reference ID/Investigator# 37704
      • Zilina, Slovakia, 1001
        • Site Reference ID/Investigator# 37707
      • Zohor, Slovakia, 90051
        • Site Reference ID/Investigator# 37869
      • Zvolen, Slovakia, 96001
        • Site Reference ID/Investigator# 37794
      • Zvolen, Slovakia, 96001
        • Site Reference ID/Investigator# 37796
      • Zvolen, Slovakia, 96001
        • Site Reference ID/Investigator# 37802
      • Zvolen, Slovakia, 96001
        • Site Reference ID/Investigator# 37803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients included in this PMOS will be those with acute tracheitis, acute tracheobronchitis, acute bronchitis, mild CAP and acute exacerbation of chronic bronchitis with infectious etiology caused probably by an atypical agent.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute Respiratory Infections
Slovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance (Was the Dosage Followed - Yes, no)
Time Frame: Day 10 - 16
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
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events
Time Frame: Day 0 through Days 10 - 16
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Temperature
Time Frame: Day 0
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
Body Temperature
Time Frame: Day 10 - 16
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
Cough and Its Character
Time Frame: Day 0
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
Cough and Its Character
Time Frame: Day 10 - 16
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
Dyspnoea
Time Frame: Day 0
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
Dyspnoea
Time Frame: Day 10 - 16
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
Auscultation
Time Frame: Day 0
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
Auscultation
Time Frame: Day 10 - 16
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Adam Hloska, M.D., Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

April 20, 2010

First Submitted That Met QC Criteria

April 20, 2010

First Posted (Estimate)

April 21, 2010

Study Record Updates

Last Update Posted (Estimate)

September 13, 2011

Last Update Submitted That Met QC Criteria

September 9, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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