Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

September 8, 2011 updated by: Abbott

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, 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 acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, 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. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

Study Overview

Status

Completed

Conditions

Detailed Description

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Study Type

Observational

Enrollment (Actual)

3130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Bilina, Czech Republic, 418 01
        • Site Reference ID/Investigator# 37381
      • Bilina, Czech Republic, 418 01
        • Site Reference ID/Investigator# 37391
      • Blansko, Czech Republic, 678 01
        • Site Reference ID/Investigator# 37282
      • Blansko, Czech Republic, 678 01
        • Site Reference ID/Investigator# 37324
      • Boskovice, Czech Republic, 680 01
        • Site Reference ID/Investigator# 37424
      • Brandys nad Labem, Czech Republic, 250 01
        • Site Reference ID/Investigator# 37329
      • Breclav, Czech Republic, 690 02
        • Site Reference ID/Investigator# 37443
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 37268
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 37299
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 37331
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 37396
      • Brno, Czech Republic, 602 00
        • Site Reference ID/Investigator# 37411
      • Brno, Czech Republic, 60200
        • Site Reference ID/Investigator# 37403
      • Brno, Czech Republic, 616 00
        • Site Reference ID/Investigator# 37380
      • Brno, Czech Republic, 636 00
        • Site Reference ID/Investigator# 37327
      • Bucovice, Czech Republic, 685 01
        • Site Reference ID/Investigator# 37429
      • Bucovice, Czech Republic, 685 01
        • Site Reference ID/Investigator# 37444
      • Budweis, Czech Republic, 370 01
        • Site Reference ID/Investigator# 37298
      • Bustehrad, Czech Republic, 273 43
        • Site Reference ID/Investigator# 37433
      • Caslav, Czech Republic, 286 01
        • Site Reference ID/Investigator# 37374
      • Ceske Budejovice, Czech Republic, 370 01
        • Site Reference ID/Investigator# 37267
      • Ceske Budejovice, Czech Republic, 370 01
        • Site Reference ID/Investigator# 37269
      • Ceske Budejovice, Czech Republic, 370 01
        • Site Reference ID/Investigator# 37302
      • Ceske Budejovice, Czech Republic, 370 05
        • Site Reference ID/Investigator# 37392
      • Ceske Budejovice, Czech Republic, 370 87
        • Site Reference ID/Investigator# 37408
      • Cheb, Czech Republic, 350 03
        • Site Reference ID/Investigator# 37362
      • Cheb, Czech Republic, 35002
        • Site Reference ID/Investigator# 47286
      • Chrudim, Czech Republic, 537 01
        • Site Reference ID/Investigator# 37413
      • Decin, Czech Republic, 405 01
        • Site Reference ID/Investigator# 37372
      • Decin, Czech Republic, 40501
        • Site Reference ID/Investigator# 37394
      • Hardec Kralove, Czech Republic, 500 02
        • Site Reference ID/Investigator# 26623
      • Hardec Kralove, Czech Republic, 500 02
        • Site Reference ID/Investigator# 37270
      • Hardec Kralove, Czech Republic, 500 02
        • Site Reference ID/Investigator# 37371
      • Hardec Kralove, Czech Republic, 500 02
        • Site Reference ID/Investigator# 43225
      • Holesov, Czech Republic, 769 01
        • Site Reference ID/Investigator# 37263
      • Holesov, Czech Republic, 769 01
        • Site Reference ID/Investigator# 43230
      • Hradek, Czech Republic, 338 42
        • Site Reference ID/Investigator# 37274
      • Hranice, Czech Republic, 753 01
        • Site Reference ID/Investigator# 37367
      • Hrebec, Czech Republic, 273 45
        • Site Reference ID/Investigator# 37364
      • Jablonec nad Nisou, Czech Republic, 466 04
        • Site Reference ID/Investigator# 37404
      • Jablonec nad Nisou, Czech Republic, 468 01
        • Site Reference ID/Investigator# 47283
      • Jaromer, Czech Republic, 551 02
        • Site Reference ID/Investigator# 43229
      • Jindrichuv Hradec, Czech Republic, 377 01
        • Site Reference ID/Investigator# 37376
      • Kaplice, Czech Republic, 382 41
        • Site Reference ID/Investigator# 37290
      • Karlovy Vary, Czech Republic, 360 01
        • Site Reference ID/Investigator# 37369
      • Karlovy Vary, Czech Republic, 360 01
        • Site Reference ID/Investigator# 37445
      • Karlovy Vary, Czech Republic, 360 17
        • Site Reference ID/Investigator# 37363
      • Kladno, Czech Republic, 272 01
        • Site Reference ID/Investigator# 37283
      • Kolin, Czech Republic, 280 02
        • Site Reference ID/Investigator# 37382
      • Konice, Czech Republic, 798 52
        • Site Reference ID/Investigator# 37368
      • Konice, Czech Republic, 798 52
        • Site Reference ID/Investigator# 37415
      • Kralovice, Czech Republic, 331 41
        • Site Reference ID/Investigator# 37272
      • Kunovice, Czech Republic, 68604
        • Site Reference ID/Investigator# 42162
      • Kyjov, Czech Republic, 697 01
        • Site Reference ID/Investigator# 43224
      • Letohrad, Czech Republic, 561 51
        • Site Reference ID/Investigator# 37323
      • Liberec, Czech Republic, 460 01
        • Site Reference ID/Investigator# 37389
      • Litomysl, Czech Republic, 570 01
        • Site Reference ID/Investigator# 37416
      • Litvinov, Czech Republic, 43542
        • Site Reference ID/Investigator# 37384
      • Marianske Lazne, Czech Republic, 353 01
        • Site Reference ID/Investigator# 37428
      • Melnik, Czech Republic, 276 01
        • Site Reference ID/Investigator# 37289
      • Mestec Kralove, Czech Republic, 289 03
        • Site Reference ID/Investigator# 37293
      • Mohelnice, Czech Republic, 78985
        • Site Reference ID/Investigator# 43228
      • Mohelnice, Czech Republic, 78985
        • Site Reference ID/Investigator# 43233
      • Moravska Trebova, Czech Republic, 571 01
        • Site Reference ID/Investigator# 43227
      • Most, Czech Republic
        • Site Reference ID/Investigator# 47290
      • Neratovice, Czech Republic, 277 11
        • Site Reference ID/Investigator# 37297
      • Novy Bor, Czech Republic, 473 01
        • Site Reference ID/Investigator# 37397
      • Novy Jicin, Czech Republic, 741 01
        • Site Reference ID/Investigator# 37303
      • Novy Jicin, Czech Republic, 741 01
        • Site Reference ID/Investigator# 37400
      • Obristvi, Czech Republic, 277 42
        • Site Reference ID/Investigator# 37399
      • Olomouc, Czech Republic, 772 00
        • Site Reference ID/Investigator# 37279
      • Olomouc, Czech Republic, 772 00
        • Site Reference ID/Investigator# 37280
      • Pardubice, Czech Republic, 530 03
        • Site Reference ID/Investigator# 37395
      • Plana, Czech Republic, 348 15
        • Site Reference ID/Investigator# 47284
      • Plzen, Czech Republic, 301 00
        • Site Reference ID/Investigator# 37271
      • Plzen, Czech Republic, 304 11
        • Site Reference ID/Investigator# 37273
      • Plzen, Czech Republic, 323 00
        • Site Reference ID/Investigator# 37423
      • Plzen, Czech Republic, 326 00
        • Site Reference ID/Investigator# 37431
      • Podebrady, Czech Republic, 290 01
        • Site Reference ID/Investigator# 37325
      • Podebrady, Czech Republic, 290 01
        • Site Reference ID/Investigator# 47282
      • Prague, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37288
      • Prague, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37300
      • Prague, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37301
      • Prague, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37330
      • Prague, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37332
      • Prague, Czech Republic, 149 00
        • Site Reference ID/Investigator# 37262
      • Prague, Czech Republic, 160 00
        • Site Reference ID/Investigator# 37275
      • Prague, Czech Republic, 181 00
        • Site Reference ID/Investigator# 37326
      • Prague, Czech Republic, 198 00
        • Site Reference ID/Investigator# 37291
      • Prague 1, Czech Republic, 141 00
        • Site Reference ID/Investigator# 37328
      • Prague 10, Czech Republic, 100 00
        • Site Reference ID/Investigator# 37375
      • Prague 14, Czech Republic, 198 00
        • Site Reference ID/Investigator# 37294
      • Prague 2, Czech Republic, 120 00
        • Site Reference ID/Investigator# 37398
      • Prague 3, Czech Republic, 130 00
        • Site Reference ID/Investigator# 37410
      • Prague 4, Czech Republic, 140 00
        • Site Reference ID/Investigator# 37387
      • Prague 4, Czech Republic, 140 00
        • Site Reference ID/Investigator# 37390
      • Prague 4, Czech Republic, 140 00
        • Site Reference ID/Investigator# 43232
      • Prague 4, Czech Republic, 140 00
        • Site Reference ID/Investigator# 43365
      • Prague 4, Czech Republic, 142 00
        • Site Reference ID/Investigator# 43236
      • Prague 5, Czech Republic, 150 00
        • Site Reference ID/Investigator# 37295
      • Prague 5, Czech Republic, 158 00
        • Site Reference ID/Investigator# 37427
      • Prague 6, Czech Republic, 163 00
        • Site Reference ID/Investigator# 37419
      • Prague 6, Czech Republic, 169 00
        • Site Reference ID/Investigator# 37438
      • Prague 9, Czech Republic, 190 00
        • Site Reference ID/Investigator# 37414
      • Prague 9, Czech Republic, 190 00
        • Site Reference ID/Investigator# 47289
      • Pribor, Czech Republic, 742 58
        • Site Reference ID/Investigator# 37378
      • Pribor, Czech Republic, 742 58
        • Site Reference ID/Investigator# 37412
      • Pribram, Czech Republic, 261 01
        • Site Reference ID/Investigator# 37432
      • Pribram, Czech Republic, 261 95
        • Site Reference ID/Investigator# 37425
      • Prostejov, Czech Republic, 796 01
        • Site Reference ID/Investigator# 37437
      • Prostejov, Czech Republic, 796 04
        • Site Reference ID/Investigator# 37430
      • Rakovnik, Czech Republic, 269 29
        • Site Reference ID/Investigator# 37442
      • Raspenava, Czech Republic, 464 01
        • Site Reference ID/Investigator# 37393
      • Roznov pod Radhostem, Czech Republic, 756 61
        • Site Reference ID/Investigator# 37421
      • Sadova, Czech Republic, 612 00
        • Site Reference ID/Investigator# 37287
      • Slapanice, Czech Republic, 664 51
        • Site Reference ID/Investigator# 37406
      • Steti, Czech Republic, 41108
        • Site Reference ID/Investigator# 37383
      • Sumperk, Czech Republic, 787 01
        • Site Reference ID/Investigator# 37278
      • Sumperk, Czech Republic, 78701
        • Site Reference ID/Investigator# 43223
      • Sumperk, Czech Republic, 78752
        • Site Reference ID/Investigator# 43234
      • Tachov, Czech Republic, 347 42
        • Site Reference ID/Investigator# 37285
      • Teplice, Czech Republic, 415 01
        • Site Reference ID/Investigator# 37386
      • Trebic, Czech Republic, 674 01
        • Site Reference ID/Investigator# 37264
      • Trebic, Czech Republic, 674 01
        • Site Reference ID/Investigator# 37277
      • Trebon, Czech Republic, 379 01
        • Site Reference ID/Investigator# 43231
      • Trinec, Czech Republic, 739 61
        • Site Reference ID/Investigator# 37405
      • Tyn, Czech Republic, 375 01
        • Site Reference ID/Investigator# 43366
      • Tyn nad Vltavou, Czech Republic, 375 01
        • Site Reference ID/Investigator# 37265
      • Uherske Hradiste, Czech Republic, 686 01
        • Site Reference ID/Investigator# 37434
      • Uhersky Brod, Czech Republic, 688 01
        • Site Reference ID/Investigator# 37365
      • Velke Pavlovice, Czech Republic, 691 06
        • Site Reference ID/Investigator# 37284
      • Vlasim, Czech Republic, 258 01
        • Site Reference ID/Investigator# 37385
      • Zamberk, Czech Republic, 56421
        • Site Reference ID/Investigator# 37322
      • Zdar nad Sazavou, Czech Republic, 591 01
        • Site Reference ID/Investigator# 37366
      • Zlin, Czech Republic, 762 75
        • Site Reference ID/Investigator# 43235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with: acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia

Description

Inclusion Criteria:

  • Men, women at least 18 years old.
  • Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.

  • Patients:

    • with acute tracheitis,
    • acute tracheobronchitis,
    • acute bronchitis,
    • mild community-acquired pneumonia or
    • acute exacerbation of chronic bronchitis

Exclusion Criteria:

  • Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Respiratory Infections
Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disappearance or Significant Alleviation of Symptoms
Time Frame: Day 8 - 16
Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
Day 8 - 16
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
Time Frame: Day 0, Day 8 - 16
Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).
Day 0, Day 8 - 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Temperature
Time Frame: Day 0, Day 8-16
Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
Day 0, Day 8-16
Bacteriological Investigation (if Available)
Time Frame: Day 0
The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
Day 0
Cough and Its Character
Time Frame: Day 0, Day 8-16
Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
Day 0, Day 8-16
Dyspnea and Its Type
Time Frame: Day 0, Day 8-16
Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
Day 0, Day 8-16
Auscultation
Time Frame: Day 0, Day 8-16
Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
Day 0, Day 8-16
Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
Time Frame: Day 0
Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
Day 0
Study Drug Given as the First, Second or Third Antimicrobial Treatment
Time Frame: Day 0
Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Day 0
Compliance
Time Frame: Day 8 - 16
Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
Day 8 - 16
Termination of Treatment Due to Noncompliance
Time Frame: Day 8 - 16
Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
Day 8 - 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Adam Hloska, M.D., Abbott Laboratories, s.r.o. (Czech Republic)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 25, 2010

First Posted (Estimate)

May 26, 2010

Study Record Updates

Last Update Posted (Estimate)

September 12, 2011

Last Update Submitted That Met QC Criteria

September 8, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P12-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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