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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

NCT ID: NCT01095978

Last Updated: 2011-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2822 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-05-31

Brief Summary

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To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format.

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 with local guidelines.

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Detailed Description

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The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period.

The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.

Conditions

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Respiratory Tract Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Acute upper respiratory tract diseases, bronchitis, pneumonia

Clarithromycin (Klacid SR)

Intervention Type DRUG

Klacid SR in a dose of 1000 mg once daily

Interventions

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Clarithromycin (Klacid SR)

Klacid SR in a dose of 1000 mg once daily

Intervention Type DRUG

Other Intervention Names

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Biaxin Abbotic Biclar Klacid Klaricid Zeclar Clarithromycin Klacid SR

Eligibility Criteria

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Inclusion Criteria

* Men, women 18 years with

1. Acute tracheitis.
2. Acute tracheobronchitis.
3. Acute bronchitis.
4. Mild community-acquired pneumonia.
5. Acute exacerbation of chronic bronchitis.
* To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.

Exclusion Criteria

* Known hypersensitivity to macrolide antibiotics
* Documented renal impairment (creatinine clearance under 30 ml/min)
* Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine
* Pregnancy
* Breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott Laboratories S.A., Ukraine

Principal Investigators

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Irina Magdik, MD

Role: STUDY_DIRECTOR

Abbott Laboratories S.A., Ukraine

Locations

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Site Reference ID/Investigator# 29842

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 29848

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30028

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30046

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30047

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30049

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30059

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30074

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30080

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30099

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30535

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30572

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30574

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30575

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30576

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30577

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30578

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30579

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30580

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30581

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30582

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30583

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30589

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30590

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30622

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30623

Dnipro, , Ukraine

Site Status

Site Reference ID/Investigator# 30050

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30051

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30054

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30057

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30060

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30066

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30071

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30073

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30573

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30584

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30585

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30600

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30601

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30586

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30587

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 30588

Donetsk, , Ukraine

Site Status

Site Reference ID/Investigator# 29840

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30052

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30056

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30058

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30065

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30067

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30075

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30076

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30078

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30079

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30096

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30102

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30616

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30617

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30624

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30625

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30626

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30627

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30628

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30632

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30633

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 40761

Kharkiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30027

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30097

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30098

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30100

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30614

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30615

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30101

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 22142

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30553

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30554

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30555

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30556

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30557

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30558

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30061

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30533

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30534

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30591

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30592

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30593

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30069

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30537

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30538

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30539

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30540

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 29839

Kiev, , Ukraine

Site Status

Site Reference ID/Investigator# 30531

Kremenchuk, , Ukraine

Site Status

Site Reference ID/Investigator# 30532

Kremenchuk, , Ukraine

Site Status

Site Reference ID/Investigator# 40759

Kyiv, , Ukraine

Site Status

Site Reference ID/Investigator# 40760

Kyiv, , Ukraine

Site Status

Site Reference ID/Investigator# 30604

Luhansk, , Ukraine

Site Status

Site Reference ID/Investigator# 30605

Luhansk, , Ukraine

Site Status

Site Reference ID/Investigator# 30606

Luhansk, , Ukraine

Site Status

Site Reference ID/Investigator# 30559

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 30561

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 30562

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 30563

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 30564

Lviv, , Ukraine

Site Status

Site Reference ID/Investigator# 29948

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 30055

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 30062

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 30594

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 30595

Odesa, , Ukraine

Site Status

Site Reference ID/Investigator# 29838

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30044

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30045

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30063

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30126

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30618

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30619

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30620

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30621

Poltava, , Ukraine

Site Status

Site Reference ID/Investigator# 30072

Simferopol, , Ukraine

Site Status

Site Reference ID/Investigator# 30629

Vynnytsya, , Ukraine

Site Status

Site Reference ID/Investigator# 30631

Vynnytsya, , Ukraine

Site Status

Site Reference ID/Investigator# 30190

Yevpatoria, , Ukraine

Site Status

Site Reference ID/Investigator# 30068

Zaporizhya, , Ukraine

Site Status

Site Reference ID/Investigator# 30565

Zaporizhya, , Ukraine

Site Status

Site Reference ID/Investigator# 30566

Zaporizhya, , Ukraine

Site Status

Site Reference ID/Investigator# 30567

Zaporizhya, , Ukraine

Site Status

Site Reference ID/Investigator# 30568

Zaporizhya, , Ukraine

Site Status

Site Reference ID/Investigator# 30570

Zaporizhya, , Ukraine

Site Status

Countries

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Ukraine

Other Identifiers

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P11-979

Identifier Type: -

Identifier Source: org_study_id

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