MedDataX Logo

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

NCT ID: NCT01108185

Last Updated: 2011-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3181 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine

NCT01095978

Respiratory Tract Infections
COMPLETED

Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

NCT01076153

Respiratory Tract Infection
COMPLETED

Recovery Time in Children With Lower Respiratory Tract Infections Treated With Klacid® Granules for Oral Suspension.

NCT01076166

Lower Respiratory Tract Infection
COMPLETED

Outcome Study to Evaluate Klaricid XL® (Clarithromycin Modified Release) in Patients With Acute Exacerbation of Chronic Bronchitis

NCT01354938

Bronchitis
COMPLETED

Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

NCT00644553

Acute Bacterial Sinusitis (ABS)
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-acquired Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adam Hloska, M.D.

Role: STUDY_DIRECTOR

Abbott

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Reference ID/Investigator# 37753

Banská Bystrica, , Slovakia

Site Status

Site Reference ID/Investigator# 37758

Banská Bystrica, , Slovakia

Site Status

Site Reference ID/Investigator# 37806

Bardejov, , Slovakia

Site Status

Site Reference ID/Investigator# 38052

Bojnice, , Slovakia

Site Status

Site Reference ID/Investigator# 37830

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37828

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37823

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37824

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37827

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37826

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37680

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37681

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37825

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37829

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37732

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37831

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37833

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37729

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37840

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37679

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37835

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37839

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37834

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37832

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37678

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37836

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37837

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37838

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37861

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37864

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37866

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 25682

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37677

Bratislava, , Slovakia

Site Status

Site Reference ID/Investigator# 37754

Brezno, , Slovakia

Site Status

Site Reference ID/Investigator# 37755

Brezno, , Slovakia

Site Status

Site Reference ID/Investigator# 37756

Brezno, , Slovakia

Site Status

Site Reference ID/Investigator# 37863

Dojč, , Slovakia

Site Status

Site Reference ID/Investigator# 38048

Dolné Vestenice, , Slovakia

Site Status

Site Reference ID/Investigator# 37694

Dolný Kubín, , Slovakia

Site Status

Site Reference ID/Investigator# 38029

Drienov, , Slovakia

Site Status

Site Reference ID/Investigator# 38056

Dudince, , Slovakia

Site Status

Site Reference ID/Investigator# 37688

Galanta, , Slovakia

Site Status

Site Reference ID/Investigator# 37703

Galanta, , Slovakia

Site Status

Site Reference ID/Investigator# 37808

Giraltovce, , Slovakia

Site Status

Site Reference ID/Investigator# 37708

Hôrka nad Váhom, , Slovakia

Site Status

Site Reference ID/Investigator# 38054

Hronské Kľačany, , Slovakia

Site Status

Site Reference ID/Investigator# 37745

Humenné, , Slovakia

Site Status

Site Reference ID/Investigator# 37752

Humenné, , Slovakia

Site Status

Site Reference ID/Investigator# 37814

Humenné, , Slovakia

Site Status

Site Reference ID/Investigator# 37815

Humenné, , Slovakia

Site Status

Site Reference ID/Investigator# 37687

Jelka, , Slovakia

Site Status

Site Reference ID/Investigator# 37737

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37740

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37741

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37744

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37767

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37788

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 38030

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 38035

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 38040

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 38043

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37742

Košice, , Slovakia

Site Status

Site Reference ID/Investigator# 37810

Levoča, , Slovakia

Site Status

Site Reference ID/Investigator# 37811

Levoča, , Slovakia

Site Status

Site Reference ID/Investigator# 37686

Likavka, , Slovakia

Site Status

Site Reference ID/Investigator# 37790

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37791

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37792

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37793

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37795

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37797

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37798

Lučenec, , Slovakia

Site Status

Site Reference ID/Investigator# 37690

Ľubochňa, , Slovakia

Site Status

Site Reference ID/Investigator# 37859

Malacky, , Slovakia

Site Status

Site Reference ID/Investigator# 37865

Malacky, , Slovakia

Site Status

Site Reference ID/Investigator# 37696

Martin, , Slovakia

Site Status

Site Reference ID/Investigator# 37702

Martin, , Slovakia

Site Status

Site Reference ID/Investigator# 37706

Martin, , Slovakia

Site Status

Site Reference ID/Investigator# 37743

Michalovce, , Slovakia

Site Status

Site Reference ID/Investigator# 37766

Michalovce, , Slovakia

Site Status

Site Reference ID/Investigator# 38028

Michalovce, , Slovakia

Site Status

Site Reference ID/Investigator# 37862

Modra, , Slovakia

Site Status

Site Reference ID/Investigator# 38042

Moldava nad Bodvou, , Slovakia

Site Status

Site Reference ID/Investigator# 37697

Námestovo, , Slovakia

Site Status

Site Reference ID/Investigator# 38041

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 38050

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 38053

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 38036

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 38038

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 38039

Nitra, , Slovakia

Site Status

Site Reference ID/Investigator# 37692

Nitrianske Pravno, , Slovakia

Site Status

Site Reference ID/Investigator# 38047

Nitrianske Rudno, , Slovakia

Site Status

Site Reference ID/Investigator# 38045

Nováky, , Slovakia

Site Status

Site Reference ID/Investigator# 38049

Oslany, , Slovakia

Site Status

Site Reference ID/Investigator# 38051

Partizánske, , Slovakia

Site Status

Site Reference ID/Investigator# 37731

Piešťany, , Slovakia

Site Status

Site Reference ID/Investigator# 37858

Piešťany, , Slovakia

Site Status

Site Reference ID/Investigator# 37812

Podhradie, , Slovakia

Site Status

Site Reference ID/Investigator# 37757

Pohorelská Maša, , Slovakia

Site Status

Site Reference ID/Investigator# 37804

Prešov, , Slovakia

Site Status

Site Reference ID/Investigator# 37809

Prešov, , Slovakia

Site Status

Site Reference ID/Investigator# 37817

Prešov, , Slovakia

Site Status

Site Reference ID/Investigator# 37789

Revúca, , Slovakia

Site Status

Site Reference ID/Investigator# 37799

Revúca, , Slovakia

Site Status

Site Reference ID/Investigator# 37762

Rimavská Sobota, , Slovakia

Site Status

Site Reference ID/Investigator# 37763

Rimavská Sobota, , Slovakia

Site Status

Site Reference ID/Investigator# 37764

Rimavská Sobota, , Slovakia

Site Status

Site Reference ID/Investigator# 37765

Rimavská Sobota, , Slovakia

Site Status

Site Reference ID/Investigator# 37800

Rožňava, , Slovakia

Site Status

Site Reference ID/Investigator# 37801

Rožňava, , Slovakia

Site Status

Site Reference ID/Investigator# 37698

Ružomberok, , Slovakia

Site Status

Site Reference ID/Investigator# 37693

Ružomberok, , Slovakia

Site Status

Site Reference ID/Investigator# 37735

Selice, , Slovakia

Site Status

Site Reference ID/Investigator# 37733

Senec, , Slovakia

Site Status

Site Reference ID/Investigator# 37730

Senica, , Slovakia

Site Status

Site Reference ID/Investigator# 38055

Slatina nad Bebravou, , Slovakia

Site Status

Site Reference ID/Investigator# 37805

Slovinky, , Slovakia

Site Status

Site Reference ID/Investigator# 38033

Snina, , Slovakia

Site Status

Site Reference ID/Investigator# 38034

Snina, , Slovakia

Site Status

Site Reference ID/Investigator# 38037

Snina, , Slovakia

Site Status

Site Reference ID/Investigator# 37746

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37747

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37748

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37750

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37751

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37813

Spišská Nová Ves, , Slovakia

Site Status

Site Reference ID/Investigator# 37736

Streda nad Bodrogom, , Slovakia

Site Status

Site Reference ID/Investigator# 38031

Streda nad Bodrogom, , Slovakia

Site Status

Site Reference ID/Investigator# 37860

Stupava, , Slovakia

Site Status

Site Reference ID/Investigator# 37816

Svidník, , Slovakia

Site Status

Site Reference ID/Investigator# 37685

Šamorín, , Slovakia

Site Status

Site Reference ID/Investigator# 38046

Topoľčany, , Slovakia

Site Status

Site Reference ID/Investigator# 37734

Trenčín, , Slovakia

Site Status

Site Reference ID/Investigator# 37699

Trenčín, , Slovakia

Site Status

Site Reference ID/Investigator# 37682

Trhová Hradská, , Slovakia

Site Status

Site Reference ID/Investigator# 37683

Trhová Hradská, , Slovakia

Site Status

Site Reference ID/Investigator# 37691

Trnava, , Slovakia

Site Status

Site Reference ID/Investigator# 37705

Trnava, , Slovakia

Site Status

Site Reference ID/Investigator# 37870

Trnava, , Slovakia

Site Status

Site Reference ID/Investigator# 37701

Trnovec nad Váhom, , Slovakia

Site Status

Site Reference ID/Investigator# 37695

Turany, , Slovakia

Site Status

Site Reference ID/Investigator# 38032

Veľké Kapušany, , Slovakia

Site Status

Site Reference ID/Investigator# 37868

Veľké Kostoľany, , Slovakia

Site Status

Site Reference ID/Investigator# 37760

Veľký Krtíš, , Slovakia

Site Status

Site Reference ID/Investigator# 37761

Veľký Krtíš, , Slovakia

Site Status

Site Reference ID/Investigator# 37807

Vranov nad Topľou, , Slovakia

Site Status

Site Reference ID/Investigator# 37867

Vrbové, , Slovakia

Site Status

Site Reference ID/Investigator# 37684

Vrútky, , Slovakia

Site Status

Site Reference ID/Investigator# 37869

Zohor, , Slovakia

Site Status

Site Reference ID/Investigator# 37794

Zvolen, , Slovakia

Site Status

Site Reference ID/Investigator# 37796

Zvolen, , Slovakia

Site Status

Site Reference ID/Investigator# 37802

Zvolen, , Slovakia

Site Status

Site Reference ID/Investigator# 37803

Zvolen, , Slovakia

Site Status

Site Reference ID/Investigator# 38044

Žabokreky nad Nitrou, , Slovakia

Site Status

Site Reference ID/Investigator# 37689

Žilina, , Slovakia

Site Status

Site Reference ID/Investigator# 37700

Žilina, , Slovakia

Site Status

Site Reference ID/Investigator# 37704

Žilina, , Slovakia

Site Status

Site Reference ID/Investigator# 37707

Žilina, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P12-060

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
NCT01075204 COMPLETED
Comparative Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin Immediate-Release Tablets for the Treatment of Exacerbation of Chronic Bronchitis
NCT00645086 COMPLETED PHASE3
A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis
NCT00649831 COMPLETED PHASE3
PERSPECTIVE: Telithromycin - Acute Exacerbation of Chronic Bronchitis
NCT00132938 COMPLETED PHASE4
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
NCT02340000 COMPLETED PHASE4
KEYS: Study Comparing Clinical Health Outcomes of Telithromycin Versus Azithromycin in Outpatients With Community-acquired Lower Respiratory Tract Infections
NCT00132951 TERMINATED PHASE4
Selection of Antibiotic Resistance by Azithromycin and Clarithromycin in the Oral Flora
NCT00354952 COMPLETED NA
Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
NCT00598897 COMPLETED PHASE4
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
NCT04016051 COMPLETED PHASE3
An Open Label Trial of Azithromycin in Chronic Productive Cough
NCT02196493 UNKNOWN PHASE3
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD
NCT00538148 COMPLETED PHASE4
Telithromycin in Respiratory Tract Infections
NCT00261105 COMPLETED PHASE4
Improving Antibiotic Prescribing for Pediatric Respiratory Infections by Family Physicians With Peer Comparison
NCT04588376 COMPLETED NA
Monotherapy Versus Bitherapy in Non-severe Hospitalized Community-acquired Pneumonia
NCT00818610 COMPLETED PHASE4
Study Comparing the Clinical Efficacy and Health Outcomes of Outpatients With Mild to Moderate Community-Acquired Pneumonia (CAP) Treated With Either Telithromycin Once Daily for 7 Days, or Azithromycin Once Daily for 5 Days
NCT00237445 TERMINATED PHASE4
Outpatient Registry Trial of Respiratory Tract Infections in Adults
NCT00245453 WITHDRAWN PHASE4
The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough
NCT01071161 COMPLETED PHASE3
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
NCT01032174 COMPLETED
TREATment of Lower Respiratory Tract Infection in Selected Hospitals in Southern Sri Lanka (TREAT-SL): a Stepped-Wedge Cluster Randomized Trial
NCT06331364 NOT_YET_RECRUITING NA
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
NCT01511107 TERMINATED PHASE2
Zithromax EV in Community-Acquired Pneumonia (CAP)
NCT00137007 COMPLETED PHASE4
Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated With Chronic Obstructive Pulmonary Disease
NCT00325897 COMPLETED NA
Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia
NCT01081964 TERMINATED PHASE2
Phase II Study of Oral Nafithromycin in CABP
NCT02903836 COMPLETED PHASE2
Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)
NCT01784770 COMPLETED