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TracheitisNCT01130883

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

An observational study of Tracheitis and Tracheobronchitis, run by Abbott at 135 sites in Czechia.

Completed

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

Official record
Search all trials

Trial summary

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… 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
3,130 participants
Where
135 sitesCzechia
Study dates
Feb 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 with: acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

135 sites in 1 country.

135 sites in 1 country

Czechia135 sites

  • Site Reference ID/Investigator# 37381

    Bílina, 418 01

  • Site Reference ID/Investigator# 37391

    Bílina, 418 01

  • Site Reference ID/Investigator# 37282

    Blansko, 678 01

  • Site Reference ID/Investigator# 37324

    Blansko, 678 01

  • Site Reference ID/Investigator# 37424

    Boskovice, 680 01

  • Site Reference ID/Investigator# 37329

    Brandýs nad Labem, 250 01

  • Site Reference ID/Investigator# 37443

    Břeclav, 690 02

  • Site Reference ID/Investigator# 37268

    Brno, 602 00

  • Site Reference ID/Investigator# 37299

    Brno, 602 00

  • Site Reference ID/Investigator# 37331

    Brno, 602 00

  • Site Reference ID/Investigator# 37396

    Brno, 602 00

  • Site Reference ID/Investigator# 37411

    Brno, 602 00

  • Site Reference ID/Investigator# 37403

    Brno, 60200

  • Site Reference ID/Investigator# 37380

    Brno, 616 00

  • Site Reference ID/Investigator# 37327

    Brno, 636 00

  • Site Reference ID/Investigator# 37429

    Bučovice, 685 01

  • Site Reference ID/Investigator# 37444

    Bučovice, 685 01

  • Site Reference ID/Investigator# 37433

    Buštěhrad, 273 43

  • Site Reference ID/Investigator# 37374

    Čáslav, 286 01

  • Site Reference ID/Investigator# 37267

    České Budějovice, 370 01

  • Site Reference ID/Investigator# 37269

    České Budějovice, 370 01

  • Site Reference ID/Investigator# 37298

    České Budějovice, 370 01

  • Site Reference ID/Investigator# 37302

    České Budějovice, 370 01

  • Site Reference ID/Investigator# 37392

    České Budějovice, 370 05

  • Site Reference ID/Investigator# 37408

    České Budějovice, 370 87

  • Site Reference ID/Investigator# 37362

    Cheb, 350 03

  • Site Reference ID/Investigator# 47286

    Cheb, 35002

  • Site Reference ID/Investigator# 37413

    Chrudim, 537 01

  • Site Reference ID/Investigator# 37372

    Děčín, 405 01

  • Site Reference ID/Investigator# 37394

    Děčín, 40501

  • Site Reference ID/Investigator# 37263

    Holešov, 769 01

  • Site Reference ID/Investigator# 43230

    Holešov, 769 01

  • Site Reference ID/Investigator# 26623

    Hradec Králové, 500 02

  • Site Reference ID/Investigator# 37270

    Hradec Králové, 500 02

  • Site Reference ID/Investigator# 37371

    Hradec Králové, 500 02

  • Site Reference ID/Investigator# 43225

    Hradec Králové, 500 02

  • Site Reference ID/Investigator# 37274

    Hrádek, 338 42

  • Site Reference ID/Investigator# 37367

    Hranice, 753 01

  • Site Reference ID/Investigator# 37364

    Hřebeč, 273 45

  • Site Reference ID/Investigator# 37404

    Jablonec nad Nisou, 466 04

  • Site Reference ID/Investigator# 47283

    Jablonec nad Nisou, 468 01

  • Site Reference ID/Investigator# 43229

    Jaroměř, 551 02

  • Site Reference ID/Investigator# 37376

    Jindřichův Hradec, 377 01

  • Site Reference ID/Investigator# 37290

    Kaplice, 382 41

  • Site Reference ID/Investigator# 37369

    Karlovy Vary, 360 01

  • Site Reference ID/Investigator# 37445

    Karlovy Vary, 360 01

  • Site Reference ID/Investigator# 37363

    Karlovy Vary, 360 17

  • Site Reference ID/Investigator# 37283

    Kladno, 272 01

  • Site Reference ID/Investigator# 37382

    Kolín, 280 02

  • Site Reference ID/Investigator# 37368

    Konice, 798 52

  • Site Reference ID/Investigator# 37415

    Konice, 798 52

  • Site Reference ID/Investigator# 37272

    Kralovice, 331 41

  • Site Reference ID/Investigator# 42162

    Kunovice, 68604

  • Site Reference ID/Investigator# 43224

    Kyjov, 697 01

  • Site Reference ID/Investigator# 37323

    Letohrad, 561 51

  • Site Reference ID/Investigator# 37389

    Liberec, 460 01

  • Site Reference ID/Investigator# 37416

    Litomyšl, 570 01

  • Site Reference ID/Investigator# 37384

    Litvínov, 43542

  • Site Reference ID/Investigator# 37428

    Mariánské Lázně, 353 01

  • Site Reference ID/Investigator# 37289

    Mělník, 276 01

  • Site Reference ID/Investigator# 37293

    Městec Králové, 289 03

  • Site Reference ID/Investigator# 43228

    Mohelnice, 78985

  • Site Reference ID/Investigator# 43233

    Mohelnice, 78985

  • Site Reference ID/Investigator# 43227

    Moravská Třebová, 571 01

  • Site Reference ID/Investigator# 47290

    Most

  • Site Reference ID/Investigator# 37297

    Neratovice, 277 11

  • Site Reference ID/Investigator# 37397

    Nový Bor, 473 01

  • Site Reference ID/Investigator# 37303

    Nový Jičín, 741 01

  • Site Reference ID/Investigator# 37400

    Nový Jičín, 741 01

  • Site Reference ID/Investigator# 37399

    Obříství, 277 42

  • Site Reference ID/Investigator# 37279

    Olomouc, 772 00

  • Site Reference ID/Investigator# 37280

    Olomouc, 772 00

  • Site Reference ID/Investigator# 37395

    Pardubice, 530 03

  • Site Reference ID/Investigator# 37271

    Pilsen, 301 00

  • Site Reference ID/Investigator# 37273

    Pilsen, 304 11

  • Site Reference ID/Investigator# 37423

    Pilsen, 323 00

  • Site Reference ID/Investigator# 37431

    Pilsen, 326 00

  • Site Reference ID/Investigator# 47284

    Planá, 348 15

  • Site Reference ID/Investigator# 37325

    Poděbrady, 290 01

  • Site Reference ID/Investigator# 47282

    Poděbrady, 290 01

  • Site Reference ID/Investigator# 37375

    Prague, 100 00

  • Site Reference ID/Investigator# 37398

    Prague, 120 00

  • Site Reference ID/Investigator# 37410

    Prague, 130 00

  • Site Reference ID/Investigator# 37387

    Prague, 140 00

  • Site Reference ID/Investigator# 37390

    Prague, 140 00

  • Site Reference ID/Investigator# 43232

    Prague, 140 00

  • Site Reference ID/Investigator# 43365

    Prague, 140 00

  • Site Reference ID/Investigator# 37288

    Prague, 141 00

  • Site Reference ID/Investigator# 37300

    Prague, 141 00

  • Site Reference ID/Investigator# 37301

    Prague, 141 00

  • Site Reference ID/Investigator# 37328

    Prague, 141 00

  • Site Reference ID/Investigator# 37330

    Prague, 141 00

  • Site Reference ID/Investigator# 37332

    Prague, 141 00

  • Site Reference ID/Investigator# 43236

    Prague, 142 00

  • Site Reference ID/Investigator# 37262

    Prague, 149 00

  • Site Reference ID/Investigator# 37295

    Prague, 150 00

  • Site Reference ID/Investigator# 37427

    Prague, 158 00

  • Site Reference ID/Investigator# 37275

    Prague, 160 00

  • Site Reference ID/Investigator# 37419

    Prague, 163 00

  • Site Reference ID/Investigator# 37438

    Prague, 169 00

  • Site Reference ID/Investigator# 37326

    Prague, 181 00

  • Site Reference ID/Investigator# 37414

    Prague, 190 00

  • Site Reference ID/Investigator# 47289

    Prague, 190 00

  • Site Reference ID/Investigator# 37291

    Prague, 198 00

  • Site Reference ID/Investigator# 37294

    Prague, 198 00

  • Site Reference ID/Investigator# 37378

    Příbor, 742 58

  • Site Reference ID/Investigator# 37412

    Příbor, 742 58

  • Site Reference ID/Investigator# 37432

    Příbram, 261 01

  • Site Reference ID/Investigator# 37425

    Příbram, 261 95

  • Site Reference ID/Investigator# 37437

    Prostějov, 796 01

  • Site Reference ID/Investigator# 37430

    Prostějov, 796 04

  • Site Reference ID/Investigator# 37442

    Rakovník, 269 29

  • Site Reference ID/Investigator# 37393

    Raspenava, 464 01

  • Site Reference ID/Investigator# 37421

    Rožnov pod Radhoštěm, 756 61

  • Site Reference ID/Investigator# 37287

    Sadová, 612 00

  • Site Reference ID/Investigator# 37406

    Šlapanice, 664 51

  • Site Reference ID/Investigator# 37383

    Štětí, 41108

  • Site Reference ID/Investigator# 37278

    Šumperk, 787 01

  • Site Reference ID/Investigator# 43223

    Šumperk, 78701

  • Site Reference ID/Investigator# 43234

    Šumperk, 78752

  • Site Reference ID/Investigator# 37285

    Tachov, 347 42

  • Site Reference ID/Investigator# 37386

    Teplice, 415 01

  • Site Reference ID/Investigator# 37264

    Třebíč, 674 01

  • Site Reference ID/Investigator# 37277

    Třebíč, 674 01

  • Site Reference ID/Investigator# 43231

    Třeboň, 379 01

  • Site Reference ID/Investigator# 37405

    Třinec, 739 61

  • Site Reference ID/Investigator# 43366

    Týn, 375 01

  • Site Reference ID/Investigator# 37265

    Týn nad Vltavou, 375 01

  • Site Reference ID/Investigator# 37434

    Uherské Hradiště, 686 01

  • Site Reference ID/Investigator# 37365

    Uherský Brod, 688 01

  • Site Reference ID/Investigator# 37284

    Velké Pavlovice, 691 06

  • Site Reference ID/Investigator# 37385

    Vlašim, 258 01

  • Site Reference ID/Investigator# 37322

    Žamberk, 56421

  • Site Reference ID/Investigator# 37366

    Zdar, 591 01

  • Site Reference ID/Investigator# 43235

    Zlín, 762 75

Other trials in Czechia

About this study

Official title: 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.

Read the 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.

Keywords
acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild 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 NCT01130883
Study groupRoleWhat they receive
Respiratory InfectionsCzech 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 being measured

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

  1. Disappearance or Significant Alleviation of Symptoms

    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.

    Measured: Day 8 - 16

  2. Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)

    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).

    Measured: Day 0, Day 8 - 16

Secondary outcomes (9)

  1. Body Temperature

    Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).

    Measured: Day 0, Day 8-16

  2. Bacteriological Investigation (if Available)

    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.

    Measured: Day 0

  3. Cough and Its Character

    Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)

    Measured: Day 0, Day 8-16

  4. Dyspnea and Its Type

    Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).

    Measured: Day 0, Day 8-16

  5. Auscultation

    Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).

    Measured: Day 0, Day 8-16

  6. Chest X-ray in Case of Community-Acquired Pneumonia (CAP)

    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.

    Measured: Day 0

  7. Study Drug Given as the First, Second or Third Antimicrobial Treatment

    Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.

    Measured: Day 0

  8. Compliance

    Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.

    Measured: Day 8 - 16

  9. Termination of Treatment Due to Noncompliance

    Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.

    Measured: Day 8 - 16

Timeline

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

  1. First posted26 May 2010 (estimated)
  2. Study startFeb 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
Observational model
Other
Time perspective
Prospective
Enrolment
3,130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130883
Sponsor's protocol ID
P12-109
Status last verified
Sep 2011
First submitted
6 May 2010
Last updated
6 Oct 2025
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 135 sites in Czechia.

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 8 inclusion and 7 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in Czechia. 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 23 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?

Disappearance or Significant Alleviation of Symptoms (time frame: Day 8 - 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 NCT01130883.

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 6 Oct 2025.

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