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TracheitisNCT01108185

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

An observational study of Tracheitis and Tracheobronchitis, run by Abbott at 158 sites in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tracheitis, Tracheobronchitis, Bronchitis
How many people
3,181 participants
Where
158 sitesSlovakia
Study dates
Mar 2010to Jul 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

158 sites in 1 country.

158 sites in 1 country

Slovakia158 sites

  • Site Reference ID/Investigator# 37753

    Banská Bystrica, 97401

  • Site Reference ID/Investigator# 37758

    Banská Bystrica, 97401

  • Site Reference ID/Investigator# 37806

    Bardejov, 08501

  • Site Reference ID/Investigator# 38052

    Bojnice, 97201

  • Site Reference ID/Investigator# 37830

    Bratislava, 81107

  • Site Reference ID/Investigator# 37828

    Bratislava, 81108

  • Site Reference ID/Investigator# 37823

    Bratislava, 82007

  • Site Reference ID/Investigator# 37824

    Bratislava, 82007

  • Site Reference ID/Investigator# 37827

    Bratislava, 82007

  • Site Reference ID/Investigator# 37826

    Bratislava, 82101

  • Site Reference ID/Investigator# 37680

    Bratislava, 82103

  • Site Reference ID/Investigator# 37681

    Bratislava, 82106

  • Site Reference ID/Investigator# 37825

    Bratislava, 82106

  • Site Reference ID/Investigator# 37829

    Bratislava, 82107

  • Site Reference ID/Investigator# 37732

    Bratislava, 83101

  • Site Reference ID/Investigator# 37831

    Bratislava, 83299

  • Site Reference ID/Investigator# 37833

    Bratislava, 83299

  • Site Reference ID/Investigator# 37729

    Bratislava, 83309

  • Site Reference ID/Investigator# 37840

    Bratislava, 83309

  • Site Reference ID/Investigator# 37679

    Bratislava, 84101

  • Site Reference ID/Investigator# 37835

    Bratislava, 84102

  • Site Reference ID/Investigator# 37839

    Bratislava, 84102

  • Site Reference ID/Investigator# 37834

    Bratislava, 84104

  • Site Reference ID/Investigator# 37832

    Bratislava, 84108

  • Site Reference ID/Investigator# 37678

    Bratislava, 84231

  • Site Reference ID/Investigator# 37836

    Bratislava, 85101

  • Site Reference ID/Investigator# 37837

    Bratislava, 85101

  • Site Reference ID/Investigator# 37838

    Bratislava, 85101

  • Site Reference ID/Investigator# 37861

    Bratislava, 85101

  • Site Reference ID/Investigator# 37864

    Bratislava, 85101

  • Site Reference ID/Investigator# 37866

    Bratislava, 85101

  • Site Reference ID/Investigator# 25682

    Bratislava, 85104

  • Site Reference ID/Investigator# 37677

    Bratislava, 85105

  • Site Reference ID/Investigator# 37754

    Brezno, 97701

  • Site Reference ID/Investigator# 37755

    Brezno, 97701

  • Site Reference ID/Investigator# 37756

    Brezno, 97701

  • Site Reference ID/Investigator# 37863

    Dojč, 90602

  • Site Reference ID/Investigator# 38048

    Dolné Vestenice, 97223

  • Site Reference ID/Investigator# 37694

    Dolný Kubín, 2601

  • Site Reference ID/Investigator# 38029

    Drienov, 08024

  • Site Reference ID/Investigator# 38056

    Dudince, 962 71

  • Site Reference ID/Investigator# 37688

    Galanta, 92401

  • Site Reference ID/Investigator# 37703

    Galanta, 92401

  • Site Reference ID/Investigator# 37808

    Giraltovce, 08701

  • Site Reference ID/Investigator# 37708

    Hôrka nad Váhom, 91632

  • Site Reference ID/Investigator# 38054

    Hronské Kľačany, 95329

  • Site Reference ID/Investigator# 37745

    Humenné, 06601

  • Site Reference ID/Investigator# 37752

    Humenné, 06601

  • Site Reference ID/Investigator# 37814

    Humenné, 06601

  • Site Reference ID/Investigator# 37815

    Humenné, 06601

  • Site Reference ID/Investigator# 37687

    Jelka, 92523

  • Site Reference ID/Investigator# 37737

    Košice, 04001

  • Site Reference ID/Investigator# 37740

    Košice, 04001

  • Site Reference ID/Investigator# 37741

    Košice, 04001

  • Site Reference ID/Investigator# 37744

    Košice, 04001

  • Site Reference ID/Investigator# 37767

    Košice, 04001

  • Site Reference ID/Investigator# 37788

    Košice, 04001

  • Site Reference ID/Investigator# 38030

    Košice, 04001

  • Site Reference ID/Investigator# 38035

    Košice, 04001

  • Site Reference ID/Investigator# 38040

    Košice, 04001

  • Site Reference ID/Investigator# 38043

    Košice, 04001

  • Site Reference ID/Investigator# 37742

    Košice, 4001

  • Site Reference ID/Investigator# 37810

    Levoča, 05401

  • Site Reference ID/Investigator# 37811

    Levoča, 05401

  • Site Reference ID/Investigator# 37686

    Likavka, 83495

  • Site Reference ID/Investigator# 37690

    Ľubochňa, 3491

  • Site Reference ID/Investigator# 37790

    Lučenec, 984 01

  • Site Reference ID/Investigator# 37791

    Lučenec, 98401

  • Site Reference ID/Investigator# 37792

    Lučenec, 98401

  • Site Reference ID/Investigator# 37793

    Lučenec, 98401

  • Site Reference ID/Investigator# 37795

    Lučenec, 98401

  • Site Reference ID/Investigator# 37797

    Lučenec, 98401

  • Site Reference ID/Investigator# 37798

    Lučenec, 98401

  • Site Reference ID/Investigator# 37859

    Malacky, 90101

  • Site Reference ID/Investigator# 37865

    Malacky, 90101

  • Site Reference ID/Investigator# 37696

    Martin, 3601

  • Site Reference ID/Investigator# 37702

    Martin, 3601

  • Site Reference ID/Investigator# 37706

    Martin, 3601

  • Site Reference ID/Investigator# 37743

    Michalovce, 07101

  • Site Reference ID/Investigator# 37766

    Michalovce, 07101

  • Site Reference ID/Investigator# 38028

    Michalovce, 07101

  • Site Reference ID/Investigator# 37862

    Modra, 90001

  • Site Reference ID/Investigator# 38042

    Moldava nad Bodvou, 04501

  • Site Reference ID/Investigator# 37697

    Námestovo, 2901

  • Site Reference ID/Investigator# 38041

    Nitra, 94901

  • Site Reference ID/Investigator# 38050

    Nitra, 94901

  • Site Reference ID/Investigator# 38053

    Nitra, 94911

  • Site Reference ID/Investigator# 38036

    Nitra, 94988

  • Site Reference ID/Investigator# 38038

    Nitra, 94988

  • Site Reference ID/Investigator# 38039

    Nitra, 94988

  • Site Reference ID/Investigator# 37692

    Nitrianske Pravno, 3822

  • Site Reference ID/Investigator# 38047

    Nitrianske Rudno, 97226

  • Site Reference ID/Investigator# 38045

    Nováky, 97271

  • Site Reference ID/Investigator# 38049

    Oslany, 97247

  • Site Reference ID/Investigator# 38051

    Partizánske, 95801

  • Site Reference ID/Investigator# 37731

    Piešťany, 92101

  • Site Reference ID/Investigator# 37858

    Piešťany, 92101

  • Site Reference ID/Investigator# 37812

    Podhradie, 05304

  • Site Reference ID/Investigator# 37757

    Pohorelská Maša, 97669

  • Site Reference ID/Investigator# 37804

    Prešov, 08001

  • Site Reference ID/Investigator# 37809

    Prešov, 08001

  • Site Reference ID/Investigator# 37817

    Prešov, 08001

  • Site Reference ID/Investigator# 37789

    Revúca, 05001

  • Site Reference ID/Investigator# 37799

    Revúca, 05001

  • Site Reference ID/Investigator# 37762

    Rimavská Sobota, 97901

  • Site Reference ID/Investigator# 37763

    Rimavská Sobota, 97901

  • Site Reference ID/Investigator# 37764

    Rimavská Sobota, 97901

  • Site Reference ID/Investigator# 37765

    Rimavská Sobota, 97901

  • Site Reference ID/Investigator# 37800

    Rožňava, 04801

  • Site Reference ID/Investigator# 37801

    Rožňava, 04801

  • Site Reference ID/Investigator# 37698

    Ružomberok, 034 01

  • Site Reference ID/Investigator# 37693

    Ružomberok, 3401

  • Site Reference ID/Investigator# 37685

    Šamorín, 93101

  • Site Reference ID/Investigator# 37735

    Selice, 92572

  • Site Reference ID/Investigator# 37733

    Senec, 90301

  • Site Reference ID/Investigator# 37730

    Senica, 90632

  • Site Reference ID/Investigator# 38055

    Slatina nad Bebravou, 95653

  • Site Reference ID/Investigator# 37805

    Slovinky, 05340

  • Site Reference ID/Investigator# 38033

    Snina, 06901

  • Site Reference ID/Investigator# 38034

    Snina, 06901

  • Site Reference ID/Investigator# 38037

    Snina, 06901

  • Site Reference ID/Investigator# 37746

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37747

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37748

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37750

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37751

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37813

    Spišská Nová Ves, 05201

  • Site Reference ID/Investigator# 37736

    Streda nad Bodrogom, 07631

  • Site Reference ID/Investigator# 38031

    Streda nad Bodrogom, 07631

  • Site Reference ID/Investigator# 37860

    Stupava, 90101

  • Site Reference ID/Investigator# 37816

    Svidník, 08901

  • Site Reference ID/Investigator# 38046

    Topoľčany, 95501

  • Site Reference ID/Investigator# 37734

    Trenčín, 91101

  • Site Reference ID/Investigator# 37699

    Trenčín, 91105

  • Site Reference ID/Investigator# 37682

    Trhová Hradská, 93013

  • Site Reference ID/Investigator# 37683

    Trhová Hradská, 93013

  • Site Reference ID/Investigator# 37691

    Trnava, 3901

  • Site Reference ID/Investigator# 37705

    Trnava, 91701

  • Site Reference ID/Investigator# 37870

    Trnava, 91701

  • Site Reference ID/Investigator# 37701

    Trnovec nad Váhom, 92571

  • Site Reference ID/Investigator# 37695

    Turany, 3853

  • Site Reference ID/Investigator# 38032

    Veľké Kapušany, 07901

  • Site Reference ID/Investigator# 37868

    Veľké Kostoľany, 92207

  • Site Reference ID/Investigator# 37760

    Veľký Krtíš, 99001

  • Site Reference ID/Investigator# 37761

    Veľký Krtíš, 99001

  • Site Reference ID/Investigator# 37807

    Vranov nad Topľou, 09301

  • Site Reference ID/Investigator# 37867

    Vrbové, 92203

  • Site Reference ID/Investigator# 37684

    Vrútky, 3861

  • Site Reference ID/Investigator# 38044

    Žabokreky nad Nitrou, 95852

  • Site Reference ID/Investigator# 37689

    Žilina, 1001

  • Site Reference ID/Investigator# 37700

    Žilina, 1001

  • Site Reference ID/Investigator# 37704

    Žilina, 1001

  • Site Reference ID/Investigator# 37707

    Žilina, 1001

  • Site Reference ID/Investigator# 37869

    Zohor, 90051

  • Site Reference ID/Investigator# 37794

    Zvolen, 96001

  • Site Reference ID/Investigator# 37796

    Zvolen, 96001

  • Site Reference ID/Investigator# 37802

    Zvolen, 96001

  • Site Reference ID/Investigator# 37803

    Zvolen, 96001

Other trials in Slovakia

About this study

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

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).

Read the 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.

Keywords
treatment with Klacid®SR, tracheitis, tracheobronchitis, bronchitis, chronic bronchitis, community-acquired pneumonia
Medical subject headings
Tracheitis, Bronchitis, Bronchitis, Chronic, Community-Acquired Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01108185
Study groupRoleWhat they receive
Acute Respiratory InfectionsSlovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 10 - 16

  2. 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.

    Measured: Day 0 through Days 10 - 16

Secondary outcomes (8)

  1. 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.

    Measured: Day 0

  2. 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.

    Measured: Day 10 - 16

  3. 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.

    Measured: Day 0

  4. 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.

    Measured: Day 10 - 16

  5. 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.

    Measured: Day 0

  6. 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.

    Measured: Day 10 - 16

  7. 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.

    Measured: Day 0

  8. 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.

    Measured: Day 10 - 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
3,181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108185
Sponsor's protocol ID
P12-060
Status last verified
Sep 2011
First submitted
20 Apr 2010
Last updated
13 Sep 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Tracheitis and Tracheobronchitis, run by Abbott at 158 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance (Was the Dosage Followed - Yes, no) (time frame: Day 10 - 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01108185.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2011.

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