Clinical trial NCT01108185: Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheitis
Tracheobronchitis
Bronchitis
Chronic Bronchitis
Community-acquired Pneumonia
Keywords: treatment with Klacid®SR
tracheitis
tracheobronchitis
bronchitis
chronic bronchitis
community-acquired pneumonia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 3181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance (Was the Dosage Followed - Yes, no)
timeFrame: Day 10 - 16
measure: The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events
timeFrame: Day 0 through Days 10 - 16
Secondary outcomes:
measure: Body Temperature
timeFrame: Day 0
measure: Body Temperature
timeFrame: Day 10 - 16
measure: Cough and Its Character
timeFrame: Day 0
measure: Cough and Its Character
timeFrame: Day 10 - 16
measure: Dyspnoea
timeFrame: Day 0
measure: Dyspnoea
timeFrame: Day 10 - 16
measure: Auscultation
timeFrame: Day 0
measure: Auscultation
timeFrame: Day 10 - 16
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
facility: Site Reference ID/Investigator# 37753
city: Banska Bystrica
country: Slovakia
facility: Site Reference ID/Investigator# 37758
city: Bardejov
country: Slovakia
facility: Site Reference ID/Investigator# 37806
city: Bojnice
country: Slovakia
facility: Site Reference ID/Investigator# 38052
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37830
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37828
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37823
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37824
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37827
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37826
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37680
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37681
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37825
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37829
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37732
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37831
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37833
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37729
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37840
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37679
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37835
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37839
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37834
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37832
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37678
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37836
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37837
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37838
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37861
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37864
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37866
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 25682
city: Bratislava
country: Slovakia
facility: Site Reference ID/Investigator# 37677
city: Brezno
country: Slovakia
facility: Site Reference ID/Investigator# 37754
city: Brezno
country: Slovakia
facility: Site Reference ID/Investigator# 37755
city: Brezno
country: Slovakia
facility: Site Reference ID/Investigator# 37756
city: Dojc
country: Slovakia
facility: Site Reference ID/Investigator# 37863
city: Dolne Vestenice
country: Slovakia
facility: Site Reference ID/Investigator# 38048
city: Dolny Kubin
country: Slovakia
facility: Site Reference ID/Investigator# 37694
city: Drienov
country: Slovakia
facility: Site Reference ID/Investigator# 38029
city: Dudince
country: Slovakia
facility: Site Reference ID/Investigator# 38056
city: Galanta
country: Slovakia
facility: Site Reference ID/Investigator# 37688
city: Galanta
country: Slovakia
facility: Site Reference ID/Investigator# 37703
city: Giraltovce
country: Slovakia
facility: Site Reference ID/Investigator# 37808
city: Horka nad Vahom
country: Slovakia
facility: Site Reference ID/Investigator# 37708
city: Hronske Klacany
country: Slovakia
facility: Site Reference ID/Investigator# 38054
city: Humenne
country: Slovakia
facility: Site Reference ID/Investigator# 37745
city: Humenne
country: Slovakia
facility: Site Reference ID/Investigator# 37752
city: Humenne
country: Slovakia
facility: Site Reference ID/Investigator# 37814
city: Humenne
country: Slovakia
facility: Site Reference ID/Investigator# 37815
city: Jelka
country: Slovakia
facility: Site Reference ID/Investigator# 37687
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37737
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37740
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37741
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37744
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37767
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37788
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 38030
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 38035
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 38040
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 38043
city: Kosice
country: Slovakia
facility: Site Reference ID/Investigator# 37742
city: Levoca
country: Slovakia
facility: Site Reference ID/Investigator# 37810
city: Levoca
country: Slovakia
facility: Site Reference ID/Investigator# 37811
city: Likavka
country: Slovakia
facility: Site Reference ID/Investigator# 37686
city: Lubochna
country: Slovakia
facility: Site Reference ID/Investigator# 37690
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37790
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37791
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37792
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37793
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37795
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37797
city: Lucenec
country: Slovakia
facility: Site Reference ID/Investigator# 37798
city: Malacky
country: Slovakia
facility: Site Reference ID/Investigator# 37859
city: Malacky
country: Slovakia
facility: Site Reference ID/Investigator# 37865
city: Martin
country: Slovakia
facility: Site Reference ID/Investigator# 37696
city: Martin
country: Slovakia
facility: Site Reference ID/Investigator# 37702
city: Martin
country: Slovakia
facility: Site Reference ID/Investigator# 37706
city: Michalovce
country: Slovakia
facility: Site Reference ID/Investigator# 37743
city: Michalovce
country: Slovakia
facility: Site Reference ID/Investigator# 37766
city: Michalovce
country: Slovakia
facility: Site Reference ID/Investigator# 38028
city: Modra
country: Slovakia
facility: Site Reference ID/Investigator# 37862
city: Moldava nad Bodvou
country: Slovakia
facility: Site Reference ID/Investigator# 38042
city: Namestovo
country: Slovakia
facility: Site Reference ID/Investigator# 37697
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38041
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38050
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38053
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38036
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38038
city: Nitra
country: Slovakia
facility: Site Reference ID/Investigator# 38039
city: Nitrianske Pravno
country: Slovakia
facility: Site Reference ID/Investigator# 37692
city: Nitrianske Rudno
country: Slovakia
facility: Site Reference ID/Investigator# 38047
city: Novaky
country: Slovakia
facility: Site Reference ID/Investigator# 38045
city: Oslany
country: Slovakia
facility: Site Reference ID/Investigator# 38049
city: Partizanske
country: Slovakia
facility: Site Reference ID/Investigator# 38051
city: Piestany
country: Slovakia
facility: Site Reference ID/Investigator# 37731
city: Piestany
country: Slovakia
facility: Site Reference ID/Investigator# 37858
city: Podhradie
country: Slovakia
facility: Site Reference ID/Investigator# 37812
city: Pohorelska Masa
country: Slovakia
facility: Site Reference ID/Investigator# 37757
city: Presov
country: Slovakia
facility: Site Reference ID/Investigator# 37804
city: Presov
country: Slovakia
facility: Site Reference ID/Investigator# 37809
city: Presov
country: Slovakia
facility: Site Reference ID/Investigator# 37817
city: Revuca
country: Slovakia
facility: Site Reference ID/Investigator# 37789
city: Revuca
country: Slovakia
facility: Site Reference ID/Investigator# 37799
city: Rimavska Sobota
country: Slovakia
facility: Site Reference ID/Investigator# 37762
city: Rimavska Sobota
country: Slovakia
facility: Site Reference ID/Investigator# 37763
city: Rimavska Sobota
country: Slovakia
facility: Site Reference ID/Investigator# 37764
city: Rimavska Sobota
country: Slovakia
facility: Site Reference ID/Investigator# 37765
city: Roznava
country: Slovakia
facility: Site Reference ID/Investigator# 37800
city: Roznava
country: Slovakia
facility: Site Reference ID/Investigator# 37801
city: Ruzomberok
country: Slovakia
facility: Site Reference ID/Investigator# 37698
city: Ruzomberok
country: Slovakia
facility: Site Reference ID/Investigator# 37693
city: Samorin
country: Slovakia
facility: Site Reference ID/Investigator# 37685
city: Selice
country: Slovakia
facility: Site Reference ID/Investigator# 37735
city: Senec
country: Slovakia
facility: Site Reference ID/Investigator# 37733
city: Senica
country: Slovakia
facility: Site Reference ID/Investigator# 37730
city: Slatina nad Bebravou
country: Slovakia
facility: Site Reference ID/Investigator# 38055
city: Slovinky
country: Slovakia
facility: Site Reference ID/Investigator# 37805
city: Snina
country: Slovakia
facility: Site Reference ID/Investigator# 38033
city: Snina
country: Slovakia
facility: Site Reference ID/Investigator# 38034
city: Snina
country: Slovakia
facility: Site Reference ID/Investigator# 38037
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37746
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37747
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37748
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37750
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37751
city: Spisska Nova Ves
country: Slovakia
facility: Site Reference ID/Investigator# 37813
city: Streda nad Bodrogom
country: Slovakia
facility: Site Reference ID/Investigator# 37736
city: Streda nad Bodrogom
country: Slovakia
facility: Site Reference ID/Investigator# 38031
city: Stupava
country: Slovakia
facility: Site Reference ID/Investigator# 37860
city: Svidnik
country: Slovakia
facility: Site Reference ID/Investigator# 37816
city: Topolcany
country: Slovakia
facility: Site Reference ID/Investigator# 38046
city: Trencin
country: Slovakia
facility: Site Reference ID/Investigator# 37734
city: Trencin
country: Slovakia
facility: Site Reference ID/Investigator# 37699
city: Trhova Hradska
country: Slovakia
facility: Site Reference ID/Investigator# 37682
city: Trhova Hradska
country: Slovakia
facility: Site Reference ID/Investigator# 37683
city: Trnava
country: Slovakia
facility: Site Reference ID/Investigator# 37691
city: Trnava
country: Slovakia
facility: Site Reference ID/Investigator# 37705
city: Trnava
country: Slovakia
facility: Site Reference ID/Investigator# 37870
city: Trnovec nad Vahom
country: Slovakia
facility: Site Reference ID/Investigator# 37701
city: Turany
country: Slovakia
facility: Site Reference ID/Investigator# 37695
city: Velke Kapusany
country: Slovakia
facility: Site Reference ID/Investigator# 38032
city: Velke Kostolany
country: Slovakia
facility: Site Reference ID/Investigator# 37868
city: Velky Krtis
country: Slovakia
facility: Site Reference ID/Investigator# 37760
city: Velky Krtis
country: Slovakia
facility: Site Reference ID/Investigator# 37761
city: Vranov nad Topľou
country: Slovakia
facility: Site Reference ID/Investigator# 37807
city: Vrbove
country: Slovakia
facility: Site Reference ID/Investigator# 37867
city: Vrutky
country: Slovakia
facility: Site Reference ID/Investigator# 37684
city: Zabokreky nad Nitrou
country: Slovakia
facility: Site Reference ID/Investigator# 38044
city: Zilina
country: Slovakia
facility: Site Reference ID/Investigator# 37689
city: Zilina
country: Slovakia
facility: Site Reference ID/Investigator# 37700
city: Zilina
country: Slovakia
facility: Site Reference ID/Investigator# 37704
city: Zilina
country: Slovakia
facility: Site Reference ID/Investigator# 37707
city: Zohor
country: Slovakia
facility: Site Reference ID/Investigator# 37869
city: Zvolen
country: Slovakia
facility: Site Reference ID/Investigator# 37794
city: Zvolen
country: Slovakia
facility: Site Reference ID/Investigator# 37796
city: Zvolen
country: Slovakia
facility: Site Reference ID/Investigator# 37802
city: Zvolen
country: Slovakia
facility: Site Reference ID/Investigator# 37803
Study officials:
affiliation: Abbott
name: Adam Hloska, M.D.
role: STUDY_DIRECTOR
References: