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

NCT01130883 | Completed Results

• 1 other identifier: P12-109
• Study Type: observational
• Target: 3,130
• Locations: 1 country
• Sites: 135

Brief 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, 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.

Conditions

Tracheitis; Tracheobronchitis; Bronchitis; Chronic Bronchitis; Community-Acquired Pneumonia (CAP)

Keywords

acute tracheitis; acute tracheobronchitis or acute bronchitis; acute exacerbation of chronic bronchitis; mild community-acquired pneumonia

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 8 - 16

• 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).

  Day 0, Day 8 - 16

Secondary Outcomes (9)

• Body Temperature

  Day 0, Day 8-16

• Bacteriological Investigation (if Available)

  Day 0

• Cough and Its Character

  Day 0, Day 8-16

• Dyspnea and Its Type

  Day 0, Day 8-16

• Auscultation

  Day 0, Day 8-16

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (135)

Site Reference ID/Investigator# 37381

Bílina, 418 01, Czechia

Location

Site Reference ID/Investigator# 37391

Bílina, 418 01, Czechia

Location

Site Reference ID/Investigator# 37282

Blansko, 678 01, Czechia

Location

Site Reference ID/Investigator# 37324

Blansko, 678 01, Czechia

Location

Site Reference ID/Investigator# 37424

Boskovice, 680 01, Czechia

Location

Site Reference ID/Investigator# 37329

Brandýs nad Labem, 250 01, Czechia

Location

Site Reference ID/Investigator# 37268

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 37299

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 37331

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 37396

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 37411

Brno, 602 00, Czechia

Location

Site Reference ID/Investigator# 37403

Brno, 60200, Czechia

Location

Site Reference ID/Investigator# 37380

Brno, 616 00, Czechia

Location

Site Reference ID/Investigator# 37327

Brno, 636 00, Czechia

Location

Site Reference ID/Investigator# 37443

Břeclav, 690 02, Czechia

Location

Site Reference ID/Investigator# 37429

Bučovice, 685 01, Czechia

Location

Site Reference ID/Investigator# 37444

Bučovice, 685 01, Czechia

Location

Site Reference ID/Investigator# 37433

Buštěhrad, 273 43, Czechia

Location

Site Reference ID/Investigator# 37362

Cheb, 350 03, Czechia

Location

Site Reference ID/Investigator# 47286

Cheb, 35002, Czechia

Location

Site Reference ID/Investigator# 37413

Chrudim, 537 01, Czechia

Location

Site Reference ID/Investigator# 37374

Čáslav, 286 01, Czechia

Location

Site Reference ID/Investigator# 37267

České Budějovice, 370 01, Czechia

Location

Site Reference ID/Investigator# 37269

České Budějovice, 370 01, Czechia

Location

Site Reference ID/Investigator# 37298

České Budějovice, 370 01, Czechia

Location

Site Reference ID/Investigator# 37302

České Budějovice, 370 01, Czechia

Location

Site Reference ID/Investigator# 37392

České Budějovice, 370 05, Czechia

Location

Site Reference ID/Investigator# 37408

České Budějovice, 370 87, Czechia

Location

Site Reference ID/Investigator# 37372

Děčín, 405 01, Czechia

Location

Site Reference ID/Investigator# 37394

Děčín, 40501, Czechia

Location

Site Reference ID/Investigator# 37263

Holešov, 769 01, Czechia

Location

Site Reference ID/Investigator# 43230

Holešov, 769 01, Czechia

Location

Site Reference ID/Investigator# 26623

Hradec Králové, 500 02, Czechia

Location

Site Reference ID/Investigator# 37270

Hradec Králové, 500 02, Czechia

Location

Site Reference ID/Investigator# 37371

Hradec Králové, 500 02, Czechia

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Site Reference ID/Investigator# 43225

Hradec Králové, 500 02, Czechia

Location

Site Reference ID/Investigator# 37367

Hranice, 753 01, Czechia

Location

Site Reference ID/Investigator# 37274

Hrádek, 338 42, Czechia

Location

Site Reference ID/Investigator# 37364

Hřebeč, 273 45, Czechia

Location

Site Reference ID/Investigator# 37404

Jablonec nad Nisou, 466 04, Czechia

Location

Site Reference ID/Investigator# 47283

Jablonec nad Nisou, 468 01, Czechia

Location

Site Reference ID/Investigator# 43229

Jaroměř, 551 02, Czechia

Location

Site Reference ID/Investigator# 37376

Jindřichův Hradec, 377 01, Czechia

Location

Site Reference ID/Investigator# 37290

Kaplice, 382 41, Czechia

Location

Site Reference ID/Investigator# 37369

Karlovy Vary, 360 01, Czechia

Location

Site Reference ID/Investigator# 37445

Karlovy Vary, 360 01, Czechia

Location

Site Reference ID/Investigator# 37363

Karlovy Vary, 360 17, Czechia

Location

Site Reference ID/Investigator# 37283

Kladno, 272 01, Czechia

Location

Site Reference ID/Investigator# 37382

Kolín, 280 02, Czechia

Location

Site Reference ID/Investigator# 37368

Konice, 798 52, Czechia

Location

Site Reference ID/Investigator# 37415

Konice, 798 52, Czechia

Location

Site Reference ID/Investigator# 37272

Kralovice, 331 41, Czechia

Location

Site Reference ID/Investigator# 42162

Kunovice, 68604, Czechia

Location

Site Reference ID/Investigator# 43224

Kyjov, 697 01, Czechia

Location

Site Reference ID/Investigator# 37323

Letohrad, 561 51, Czechia

Location

Site Reference ID/Investigator# 37389

Liberec, 460 01, Czechia

Location

Site Reference ID/Investigator# 37416

Litomyšl, 570 01, Czechia

Location

Site Reference ID/Investigator# 37384

Litvínov, 43542, Czechia

Location

Site Reference ID/Investigator# 37428

Mariánské Lázně, 353 01, Czechia

Location

Site Reference ID/Investigator# 37289

Mělník, 276 01, Czechia

Location

Site Reference ID/Investigator# 37293

Městec Králové, 289 03, Czechia

Location

Site Reference ID/Investigator# 43228

Mohelnice, 78985, Czechia

Location

Site Reference ID/Investigator# 43233

Mohelnice, 78985, Czechia

Location

Site Reference ID/Investigator# 43227

Moravská Třebová, 571 01, Czechia

Location

Site Reference ID/Investigator# 47290

Most, Czechia

Location

Site Reference ID/Investigator# 37297

Neratovice, 277 11, Czechia

Location

Site Reference ID/Investigator# 37397

Nový Bor, 473 01, Czechia

Location

Site Reference ID/Investigator# 37303

Nový Jičín, 741 01, Czechia

Location

Site Reference ID/Investigator# 37400

Nový Jičín, 741 01, Czechia

Location

Site Reference ID/Investigator# 37399

Obříství, 277 42, Czechia

Location

Site Reference ID/Investigator# 37279

Olomouc, 772 00, Czechia

Location

Site Reference ID/Investigator# 37280

Olomouc, 772 00, Czechia

Location

Site Reference ID/Investigator# 37395

Pardubice, 530 03, Czechia

Location

Site Reference ID/Investigator# 37271

Pilsen, 301 00, Czechia

Location

Site Reference ID/Investigator# 37273

Pilsen, 304 11, Czechia

Location

Site Reference ID/Investigator# 37423

Pilsen, 323 00, Czechia

Location

Site Reference ID/Investigator# 37431

Pilsen, 326 00, Czechia

Location

Site Reference ID/Investigator# 47284

Planá, 348 15, Czechia

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Site Reference ID/Investigator# 37325

Poděbrady, 290 01, Czechia

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Site Reference ID/Investigator# 47282

Poděbrady, 290 01, Czechia

Location

Site Reference ID/Investigator# 37375

Prague, 100 00, Czechia

Location

Site Reference ID/Investigator# 37398

Prague, 120 00, Czechia

Location

Site Reference ID/Investigator# 37410

Prague, 130 00, Czechia

Location

Site Reference ID/Investigator# 37387

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 37390

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 43232

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 43365

Prague, 140 00, Czechia

Location

Site Reference ID/Investigator# 37288

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 37300

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 37301

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 37328

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 37330

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 37332

Prague, 141 00, Czechia

Location

Site Reference ID/Investigator# 43236

Prague, 142 00, Czechia

Location

Site Reference ID/Investigator# 37262

Prague, 149 00, Czechia

Location

Site Reference ID/Investigator# 37295

Prague, 150 00, Czechia

Location

Site Reference ID/Investigator# 37427

Prague, 158 00, Czechia

Location

Site Reference ID/Investigator# 37275

Prague, 160 00, Czechia

Location

Site Reference ID/Investigator# 37419

Prague, 163 00, Czechia

Location

Site Reference ID/Investigator# 37438

Prague, 169 00, Czechia

Location

Site Reference ID/Investigator# 37326

Prague, 181 00, Czechia

Location

Site Reference ID/Investigator# 37414

Prague, 190 00, Czechia

Location

Site Reference ID/Investigator# 47289

Prague, 190 00, Czechia

Location

Site Reference ID/Investigator# 37291

Prague, 198 00, Czechia

Location

Site Reference ID/Investigator# 37294

Prague, 198 00, Czechia

Location

Site Reference ID/Investigator# 37437

Prostějov, 796 01, Czechia

Location

Site Reference ID/Investigator# 37430

Prostějov, 796 04, Czechia

Location

Site Reference ID/Investigator# 37378

Příbor, 742 58, Czechia

Location

Site Reference ID/Investigator# 37412

Příbor, 742 58, Czechia

Location

Site Reference ID/Investigator# 37432

Příbram, 261 01, Czechia

Location

Site Reference ID/Investigator# 37425

Příbram, 261 95, Czechia

Location

Site Reference ID/Investigator# 37442

Rakovník, 269 29, Czechia

Location

Site Reference ID/Investigator# 37393

Raspenava, 464 01, Czechia

Location

Site Reference ID/Investigator# 37421

Rožnov pod Radhoštěm, 756 61, Czechia

Location

Site Reference ID/Investigator# 37287

Sadová, 612 00, Czechia

Location

Site Reference ID/Investigator# 37406

Šlapanice, 664 51, Czechia

Location

Site Reference ID/Investigator# 37383

Štětí, 41108, Czechia

Location

Site Reference ID/Investigator# 37278

Šumperk, 787 01, Czechia

Location

Site Reference ID/Investigator# 43223

Šumperk, 78701, Czechia

Location

Site Reference ID/Investigator# 43234

Šumperk, 78752, Czechia

Location

Site Reference ID/Investigator# 37285

Tachov, 347 42, Czechia

Location

Site Reference ID/Investigator# 37386

Teplice, 415 01, Czechia

Location

Site Reference ID/Investigator# 37264

Třebíč, 674 01, Czechia

Location

Site Reference ID/Investigator# 37277

Třebíč, 674 01, Czechia

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Site Reference ID/Investigator# 43231

Třeboň, 379 01, Czechia

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Site Reference ID/Investigator# 37405

Třinec, 739 61, Czechia

Location

Site Reference ID/Investigator# 43366

Týn, 375 01, Czechia

Location

Site Reference ID/Investigator# 37265

Týn nad Vltavou, 375 01, Czechia

Location

Site Reference ID/Investigator# 37434

Uherské Hradiště, 686 01, Czechia

Location

Site Reference ID/Investigator# 37365

Uherský Brod, 688 01, Czechia

Location

Site Reference ID/Investigator# 37284

Velké Pavlovice, 691 06, Czechia

Location

Site Reference ID/Investigator# 37385

Vlašim, 258 01, Czechia

Location

Site Reference ID/Investigator# 37366

Zdar, 591 01, Czechia

Location

Site Reference ID/Investigator# 43235

Zlín, 762 75, Czechia

Location

Site Reference ID/Investigator# 37322

Žamberk, 56421, Czechia

Location

MeSH Terms

Conditions

Tracheitis; Bronchitis; Bronchitis, Chronic; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Tracheal Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Community-Acquired Infections; Pneumonia

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Adam Hloska, M.D.

  Abbott Laboratories, s.r.o. (Czech Republic)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 26, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 6, 2025
• Results First Posted: August 23, 2011

Record last verified: 2011-09

Locations

CZ (135)