Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection
- Conditions
- TracheitisTracheobronchitisBronchitisChronic BronchitisCommunity-acquired Pneumonia
- Registration Number
- NCT01108185
- Lead Sponsor
- Abbott
- Brief 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3181
-
Men, women at least 18 years old
- with acute tracheitis,
- acute tracheobronchitis,
- acute bronchitis,
- mild community-acquired pneumonia or
- acute exacerbation of chronic bronchitis
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compliance (Was the Dosage Followed - Yes, no) 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.
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events 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.
- Secondary Outcome Measures
Name Time Method Body Temperature 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.
Cough and Its Character 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.
Dyspnoea 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.
Auscultation 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.
Trial Locations
- Locations (158)
Site Reference ID/Investigator# 37753
🇸🇰Banska Bystrica, Slovakia
Site Reference ID/Investigator# 37758
🇸🇰Banska Bystrica, Slovakia
Site Reference ID/Investigator# 37827
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 38052
🇸🇰Bojnice, Slovakia
Site Reference ID/Investigator# 37825
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37837
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37755
🇸🇰Brezno, Slovakia
Site Reference ID/Investigator# 37694
🇸🇰Dolny Kubin, Slovakia
Site Reference ID/Investigator# 38029
🇸🇰Drienov, Slovakia
Site Reference ID/Investigator# 37681
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37806
🇸🇰Bardejov, Slovakia
Site Reference ID/Investigator# 37828
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37823
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37679
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37756
🇸🇰Brezno, Slovakia
Site Reference ID/Investigator# 37830
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37826
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37839
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37680
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37829
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 25682
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 38056
🇸🇰Dudince, Slovakia
Site Reference ID/Investigator# 38054
🇸🇰Hronske Klacany, Slovakia
Site Reference ID/Investigator# 37745
🇸🇰Humenne, Slovakia
Site Reference ID/Investigator# 37814
🇸🇰Humenne, Slovakia
Site Reference ID/Investigator# 37838
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37864
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37863
🇸🇰Dojc, Slovakia
Site Reference ID/Investigator# 37767
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 37788
🇸🇰Kosice, 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# 37744
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 38043
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 37686
🇸🇰Likavka, Slovakia
Site Reference ID/Investigator# 37690
🇸🇰Lubochna, Slovakia
Site Reference ID/Investigator# 37793
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 38028
🇸🇰Michalovce, Slovakia
Site Reference ID/Investigator# 38042
🇸🇰Moldava nad Bodvou, Slovakia
Site Reference ID/Investigator# 38038
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 38046
🇸🇰Topolcany, Slovakia
Site Reference ID/Investigator# 37790
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37798
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37859
🇸🇰Malacky, Slovakia
Site Reference ID/Investigator# 37791
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37795
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37797
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37865
🇸🇰Malacky, Slovakia
Site Reference ID/Investigator# 37696
🇸🇰Martin, Slovakia
Site Reference ID/Investigator# 37816
🇸🇰Svidnik, Slovakia
Site Reference ID/Investigator# 37689
🇸🇰Zilina, Slovakia
Site Reference ID/Investigator# 37702
🇸🇰Martin, Slovakia
Site Reference ID/Investigator# 37743
🇸🇰Michalovce, Slovakia
Site Reference ID/Investigator# 37862
🇸🇰Modra, Slovakia
Site Reference ID/Investigator# 38033
🇸🇰Snina, Slovakia
Site Reference ID/Investigator# 37697
🇸🇰Namestovo, Slovakia
Site Reference ID/Investigator# 38037
🇸🇰Snina, Slovakia
Site Reference ID/Investigator# 38050
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 37805
🇸🇰Slovinky, Slovakia
Site Reference ID/Investigator# 37833
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37835
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37732
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37831
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37708
🇸🇰Horka nad Vahom, Slovakia
Site Reference ID/Investigator# 37752
🇸🇰Humenne, Slovakia
Site Reference ID/Investigator# 37729
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37840
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37834
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37832
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37861
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37677
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37754
🇸🇰Brezno, Slovakia
Site Reference ID/Investigator# 37678
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 38048
🇸🇰Dolne Vestenice, Slovakia
Site Reference ID/Investigator# 37808
🇸🇰Giraltovce, Slovakia
Site Reference ID/Investigator# 37811
🇸🇰Levoca, Slovakia
Site Reference ID/Investigator# 38035
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 38040
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 37742
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 37810
🇸🇰Levoca, Slovakia
Site Reference ID/Investigator# 37812
🇸🇰Podhradie, Slovakia
Site Reference ID/Investigator# 37804
🇸🇰Presov, Slovakia
Site Reference ID/Investigator# 37813
🇸🇰Spisska Nova Ves, Slovakia
Site Reference ID/Investigator# 37802
🇸🇰Zvolen, Slovakia
Site Reference ID/Investigator# 37803
🇸🇰Zvolen, Slovakia
Site Reference ID/Investigator# 37824
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37836
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37866
🇸🇰Bratislava, Slovakia
Site Reference ID/Investigator# 37688
🇸🇰Galanta, Slovakia
Site Reference ID/Investigator# 37815
🇸🇰Humenne, Slovakia
Site Reference ID/Investigator# 37703
🇸🇰Galanta, Slovakia
Site Reference ID/Investigator# 38030
🇸🇰Kosice, Slovakia
Site Reference ID/Investigator# 37792
🇸🇰Lucenec, Slovakia
Site Reference ID/Investigator# 37706
🇸🇰Martin, Slovakia
Site Reference ID/Investigator# 38041
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 37766
🇸🇰Michalovce, Slovakia
Site Reference ID/Investigator# 38053
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 38036
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 38039
🇸🇰Nitra, Slovakia
Site Reference ID/Investigator# 37692
🇸🇰Nitrianske Pravno, Slovakia
Site Reference ID/Investigator# 38045
🇸🇰Novaky, Slovakia
Site Reference ID/Investigator# 38047
🇸🇰Nitrianske Rudno, 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# 37817
🇸🇰Presov, Slovakia
Site Reference ID/Investigator# 37809
🇸🇰Presov, Slovakia
Site Reference ID/Investigator# 37789
🇸🇰Revuca, Slovakia
Site Reference ID/Investigator# 37757
🇸🇰Pohorelska Masa, Slovakia
Site Reference ID/Investigator# 37762
🇸🇰Rimavska Sobota, Slovakia
Site Reference ID/Investigator# 37799
🇸🇰Revuca, Slovakia
Site Reference ID/Investigator# 37764
🇸🇰Rimavska Sobota, Slovakia
Site Reference ID/Investigator# 37763
🇸🇰Rimavska Sobota, Slovakia
Site Reference ID/Investigator# 37800
🇸🇰Roznava, Slovakia
Site Reference ID/Investigator# 37765
🇸🇰Rimavska Sobota, Slovakia
Site Reference ID/Investigator# 38055
🇸🇰Slatina nad Bebravou, Slovakia
Site Reference ID/Investigator# 37693
🇸🇰Ruzomberok, Slovakia
Site Reference ID/Investigator# 37685
🇸🇰Samorin, Slovakia
Site Reference ID/Investigator# 37801
🇸🇰Roznava, Slovakia
Site Reference ID/Investigator# 37735
🇸🇰Selice, Slovakia
Site Reference ID/Investigator# 37698
🇸🇰Ruzomberok, Slovakia
Site Reference ID/Investigator# 37730
🇸🇰Senica, Slovakia
Site Reference ID/Investigator# 37733
🇸🇰Senec, Slovakia
Site Reference ID/Investigator# 38034
🇸🇰Snina, Slovakia
Site Reference ID/Investigator# 37746
🇸🇰Spisska Nova Ves, Slovakia
Site Reference ID/Investigator# 37747
🇸🇰Spisska Nova Ves, Slovakia
Site Reference ID/Investigator# 37750
🇸🇰Spisska Nova Ves, Slovakia
Site Reference ID/Investigator# 37748
🇸🇰Spisska Nova Ves, Slovakia
Site Reference ID/Investigator# 37751
🇸🇰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# 37734
🇸🇰Trencin, Slovakia
Site Reference ID/Investigator# 37699
🇸🇰Trencin, Slovakia
Site Reference ID/Investigator# 37705
🇸🇰Trnava, Slovakia
Site Reference ID/Investigator# 37682
🇸🇰Trhova Hradska, Slovakia
Site Reference ID/Investigator# 37701
🇸🇰Trnovec nad Vahom, Slovakia
Site Reference ID/Investigator# 37683
🇸🇰Trhova Hradska, Slovakia
Site Reference ID/Investigator# 37691
🇸🇰Trnava, Slovakia
Site Reference ID/Investigator# 37870
🇸🇰Trnava, Slovakia
Site Reference ID/Investigator# 38032
🇸🇰Velke Kapusany, Slovakia
Site Reference ID/Investigator# 37695
🇸🇰Turany, 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 Topľou, Slovakia
Site Reference ID/Investigator# 37867
🇸🇰Vrbove, Slovakia
Site Reference ID/Investigator# 37700
🇸🇰Zilina, Slovakia
Site Reference ID/Investigator# 37684
🇸🇰Vrutky, Slovakia
Site Reference ID/Investigator# 37704
🇸🇰Zilina, Slovakia
Site Reference ID/Investigator# 37869
🇸🇰Zohor, Slovakia
Site Reference ID/Investigator# 38044
🇸🇰Zabokreky nad Nitrou, Slovakia
Site Reference ID/Investigator# 37707
🇸🇰Zilina, Slovakia
Site Reference ID/Investigator# 37794
🇸🇰Zvolen, Slovakia
Site Reference ID/Investigator# 37796
🇸🇰Zvolen, Slovakia