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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

3,181

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach

1 country

158 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

March 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2011

Completed

Last Updated

September 13, 2011

Status Verified

September 1, 2011

Enrollment Period

4 months

First QC Date

April 20, 2010

Results QC Date

July 26, 2011

Last Update Submit

September 9, 2011

Conditions

Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-acquired Pneumonia

Keywords

treatment with Klacid®SRtracheitistracheobronchitisbronchitischronic bronchitiscommunity-acquired pneumonia

Outcome Measures

Primary Outcomes (2)

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
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

Secondary Outcomes (8)

Body Temperature
Day 0
Body Temperature
Day 10 - 16
Cough and Its Character
Day 0
Cough and Its Character
Day 10 - 16
Dyspnoea
Day 0
+3 more secondary outcomes

Study Arms (1)

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).

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

You may qualify if:

Men, women at least 18 years old
with acute tracheitis,
acute tracheobronchitis,
acute bronchitis,
mild community-acquired pneumonia or
acute exacerbation of chronic bronchitis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Abbottlead

Study Sites (158)

Site Reference ID/Investigator# 37753

Banská Bystrica, 97401, Slovakia

Location

Site Reference ID/Investigator# 37758

Banská Bystrica, 97401, Slovakia

Location

Site Reference ID/Investigator# 37806

Bardejov, 08501, Slovakia

Location

Site Reference ID/Investigator# 38052

Bojnice, 97201, Slovakia

Location

Site Reference ID/Investigator# 37830

Bratislava, 81107, Slovakia

Location

Site Reference ID/Investigator# 37828

Bratislava, 81108, Slovakia

Location

Site Reference ID/Investigator# 37823

Bratislava, 82007, Slovakia

Location

Site Reference ID/Investigator# 37824

Bratislava, 82007, Slovakia

Location

Site Reference ID/Investigator# 37827

Bratislava, 82007, Slovakia

Location

Site Reference ID/Investigator# 37826

Bratislava, 82101, Slovakia

Location

Site Reference ID/Investigator# 37680

Bratislava, 82103, Slovakia

Location

Site Reference ID/Investigator# 37681

Bratislava, 82106, Slovakia

Location

Site Reference ID/Investigator# 37825

Bratislava, 82106, Slovakia

Location

Site Reference ID/Investigator# 37829

Bratislava, 82107, Slovakia

Location

Site Reference ID/Investigator# 37732

Bratislava, 83101, Slovakia

Location

Site Reference ID/Investigator# 37831

Bratislava, 83299, Slovakia

Location

Site Reference ID/Investigator# 37833

Bratislava, 83299, Slovakia

Location

Site Reference ID/Investigator# 37729

Bratislava, 83309, Slovakia

Location

Site Reference ID/Investigator# 37840

Bratislava, 83309, Slovakia

Location

Site Reference ID/Investigator# 37679

Bratislava, 84101, Slovakia

Location

Site Reference ID/Investigator# 37835

Bratislava, 84102, Slovakia

Location

Site Reference ID/Investigator# 37839

Bratislava, 84102, Slovakia

Location

Site Reference ID/Investigator# 37834

Bratislava, 84104, Slovakia

Location

Site Reference ID/Investigator# 37832

Bratislava, 84108, Slovakia

Location

Site Reference ID/Investigator# 37678

Bratislava, 84231, Slovakia

Location

Site Reference ID/Investigator# 37836

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 37837

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 37838

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 37861

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 37864

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 37866

Bratislava, 85101, Slovakia

Location

Site Reference ID/Investigator# 25682

Bratislava, 85104, Slovakia

Location

Site Reference ID/Investigator# 37677

Bratislava, 85105, Slovakia

Location

Site Reference ID/Investigator# 37754

Brezno, 97701, Slovakia

Location

Site Reference ID/Investigator# 37755

Brezno, 97701, Slovakia

Location

Site Reference ID/Investigator# 37756

Brezno, 97701, Slovakia

Location

Site Reference ID/Investigator# 37863

Dojč, 90602, Slovakia

Location

Site Reference ID/Investigator# 38048

Dolné Vestenice, 97223, Slovakia

Location

Site Reference ID/Investigator# 37694

Dolný Kubín, 2601, Slovakia

Location

Site Reference ID/Investigator# 38029

Drienov, 08024, Slovakia

Location

Site Reference ID/Investigator# 38056

Dudince, 962 71, Slovakia

Location

Site Reference ID/Investigator# 37688

Galanta, 92401, Slovakia

Location

Site Reference ID/Investigator# 37703

Galanta, 92401, Slovakia

Location

Site Reference ID/Investigator# 37808

Giraltovce, 08701, Slovakia

Location

Site Reference ID/Investigator# 37708

Hôrka nad Váhom, 91632, Slovakia

Location

Site Reference ID/Investigator# 38054

Hronské Kľačany, 95329, Slovakia

Location

Site Reference ID/Investigator# 37745

Humenné, 06601, Slovakia

Location

Site Reference ID/Investigator# 37752

Humenné, 06601, Slovakia

Location

Site Reference ID/Investigator# 37814

Humenné, 06601, Slovakia

Location

Site Reference ID/Investigator# 37815

Humenné, 06601, Slovakia

Location

Site Reference ID/Investigator# 37687

Jelka, 92523, Slovakia

Location

Site Reference ID/Investigator# 37737

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37740

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37741

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37744

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37767

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37788

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 38030

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 38035

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 38040

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 38043

Košice, 04001, Slovakia

Location

Site Reference ID/Investigator# 37742

Košice, 4001, Slovakia

Location

Site Reference ID/Investigator# 37810

Levoča, 05401, Slovakia

Location

Site Reference ID/Investigator# 37811

Levoča, 05401, Slovakia

Location

Site Reference ID/Investigator# 37686

Likavka, 83495, Slovakia

Location

Site Reference ID/Investigator# 37790

Lučenec, 984 01, Slovakia

Location

Site Reference ID/Investigator# 37791

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37792

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37793

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37795

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37797

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37798

Lučenec, 98401, Slovakia

Location

Site Reference ID/Investigator# 37690

Ľubochňa, 3491, Slovakia

Location

Site Reference ID/Investigator# 37859

Malacky, 90101, Slovakia

Location

Site Reference ID/Investigator# 37865

Malacky, 90101, Slovakia

Location

Site Reference ID/Investigator# 37696

Martin, 3601, Slovakia

Location

Site Reference ID/Investigator# 37702

Martin, 3601, Slovakia

Location

Site Reference ID/Investigator# 37706

Martin, 3601, Slovakia

Location

Site Reference ID/Investigator# 37743

Michalovce, 07101, Slovakia

Location

Site Reference ID/Investigator# 37766

Michalovce, 07101, Slovakia

Location

Site Reference ID/Investigator# 38028

Michalovce, 07101, Slovakia

Location

Site Reference ID/Investigator# 37862

Modra, 90001, Slovakia

Location

Site Reference ID/Investigator# 38042

Moldava nad Bodvou, 04501, Slovakia

Location

Site Reference ID/Investigator# 37697

Námestovo, 2901, Slovakia

Location

Site Reference ID/Investigator# 38041

Nitra, 94901, Slovakia

Location

Site Reference ID/Investigator# 38050

Nitra, 94901, Slovakia

Location

Site Reference ID/Investigator# 38053

Nitra, 94911, Slovakia

Location

Site Reference ID/Investigator# 38036

Nitra, 94988, Slovakia

Location

Site Reference ID/Investigator# 38038

Nitra, 94988, Slovakia

Location

Site Reference ID/Investigator# 38039

Nitra, 94988, Slovakia

Location

Site Reference ID/Investigator# 37692

Nitrianske Pravno, 3822, Slovakia

Location

Site Reference ID/Investigator# 38047

Nitrianske Rudno, 97226, Slovakia

Location

Site Reference ID/Investigator# 38045

Nováky, 97271, Slovakia

Location

Site Reference ID/Investigator# 38049

Oslany, 97247, Slovakia

Location

Site Reference ID/Investigator# 38051

Partizánske, 95801, Slovakia

Location

Site Reference ID/Investigator# 37731

Piešťany, 92101, Slovakia

Location

Site Reference ID/Investigator# 37858

Piešťany, 92101, Slovakia

Location

Site Reference ID/Investigator# 37812

Podhradie, 05304, Slovakia

Location

Site Reference ID/Investigator# 37757

Pohorelská Maša, 97669, Slovakia

Location

Site Reference ID/Investigator# 37804

Prešov, 08001, Slovakia

Location

Site Reference ID/Investigator# 37809

Prešov, 08001, Slovakia

Location

Site Reference ID/Investigator# 37817

Prešov, 08001, Slovakia

Location

Site Reference ID/Investigator# 37789

Revúca, 05001, Slovakia

Location

Site Reference ID/Investigator# 37799

Revúca, 05001, Slovakia

Location

Site Reference ID/Investigator# 37762

Rimavská Sobota, 97901, Slovakia

Location

Site Reference ID/Investigator# 37763

Rimavská Sobota, 97901, Slovakia

Location

Site Reference ID/Investigator# 37764

Rimavská Sobota, 97901, Slovakia

Location

Site Reference ID/Investigator# 37765

Rimavská Sobota, 97901, Slovakia

Location

Site Reference ID/Investigator# 37800

Rožňava, 04801, Slovakia

Location

Site Reference ID/Investigator# 37801

Rožňava, 04801, Slovakia

Location

Site Reference ID/Investigator# 37698

Ružomberok, 034 01, Slovakia

Location

Site Reference ID/Investigator# 37693

Ružomberok, 3401, Slovakia

Location

Site Reference ID/Investigator# 37735

Selice, 92572, Slovakia

Location

Site Reference ID/Investigator# 37733

Senec, 90301, Slovakia

Location

Site Reference ID/Investigator# 37730

Senica, 90632, Slovakia

Location

Site Reference ID/Investigator# 38055

Slatina nad Bebravou, 95653, Slovakia

Location

Site Reference ID/Investigator# 37805

Slovinky, 05340, Slovakia

Location

Site Reference ID/Investigator# 38033

Snina, 06901, Slovakia

Location

Site Reference ID/Investigator# 38034

Snina, 06901, Slovakia

Location

Site Reference ID/Investigator# 38037

Snina, 06901, Slovakia

Location

Site Reference ID/Investigator# 37746