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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01108185
Other study ID # P12-060
Secondary ID
Status Completed
Phase N/A
First received April 20, 2010
Last updated September 9, 2011
Start date March 2010
Est. completion date July 2010

Study information

Verified date September 2011
Source Abbott
Contact n/a
Is FDA regulated No
Health authority Slovak Republic: Ethics Committee
Study type Observational

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

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

Study Design

Time Perspective: Prospective


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Abbott

Country where clinical trial is conducted

Slovakia, 

Outcome

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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