Clinical trial NCT01130883: Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-26
Enrollment: 3130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disappearance or Significant Alleviation of Symptoms
timeFrame: Day 8 - 16
measure: Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
timeFrame: Day 0, Day 8 - 16
Secondary outcomes:
measure: Body Temperature
timeFrame: Day 0, Day 8-16
measure: Bacteriological Investigation (if Available)
timeFrame: Day 0
measure: Cough and Its Character
timeFrame: Day 0, Day 8-16
measure: Dyspnea and Its Type
timeFrame: Day 0, Day 8-16
measure: Auscultation
timeFrame: Day 0, Day 8-16
measure: Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
timeFrame: Day 0
measure: Study Drug Given as the First, Second or Third Antimicrobial Treatment
timeFrame: Day 0
measure: Compliance
timeFrame: Day 8 - 16
measure: Termination of Treatment Due to Noncompliance
timeFrame: Day 8 - 16
Other outcomes:
Locations:
city: Bilina
country: Czech Republic
facility: Site Reference ID/Investigator# 37381
city: Bilina
country: Czech Republic
facility: Site Reference ID/Investigator# 37391
city: Blansko
country: Czech Republic
facility: Site Reference ID/Investigator# 37282
city: Blansko
country: Czech Republic
facility: Site Reference ID/Investigator# 37324
city: Boskovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37424
city: Brandys nad Labem
country: Czech Republic
facility: Site Reference ID/Investigator# 37329
city: Breclav
country: Czech Republic
facility: Site Reference ID/Investigator# 37443
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37268
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37299
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37331
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37396
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37411
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37403
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37380
city: Brno
country: Czech Republic
facility: Site Reference ID/Investigator# 37327
city: Bucovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37429
city: Bucovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37444
city: Budweis
country: Czech Republic
facility: Site Reference ID/Investigator# 37298
city: Bustehrad
country: Czech Republic
facility: Site Reference ID/Investigator# 37433
city: Caslav
country: Czech Republic
facility: Site Reference ID/Investigator# 37374
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37267
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37269
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37302
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37392
city: Ceske Budejovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37408
city: Cheb
country: Czech Republic
facility: Site Reference ID/Investigator# 37362
city: Cheb
country: Czech Republic
facility: Site Reference ID/Investigator# 47286
city: Chrudim
country: Czech Republic
facility: Site Reference ID/Investigator# 37413
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 37372
city: Decin
country: Czech Republic
facility: Site Reference ID/Investigator# 37394
city: Hardec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 26623
city: Hardec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 37270
city: Hardec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 37371
city: Hardec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 43225
city: Holesov
country: Czech Republic
facility: Site Reference ID/Investigator# 37263
city: Holesov
country: Czech Republic
facility: Site Reference ID/Investigator# 43230
city: Hradek
country: Czech Republic
facility: Site Reference ID/Investigator# 37274
city: Hranice
country: Czech Republic
facility: Site Reference ID/Investigator# 37367
city: Hrebec
country: Czech Republic
facility: Site Reference ID/Investigator# 37364
city: Jablonec nad Nisou
country: Czech Republic
facility: Site Reference ID/Investigator# 37404
city: Jablonec nad Nisou
country: Czech Republic
facility: Site Reference ID/Investigator# 47283
city: Jaromer
country: Czech Republic
facility: Site Reference ID/Investigator# 43229
city: Jindrichuv Hradec
country: Czech Republic
facility: Site Reference ID/Investigator# 37376
city: Kaplice
country: Czech Republic
facility: Site Reference ID/Investigator# 37290
city: Karlovy Vary
country: Czech Republic
facility: Site Reference ID/Investigator# 37369
city: Karlovy Vary
country: Czech Republic
facility: Site Reference ID/Investigator# 37445
city: Karlovy Vary
country: Czech Republic
facility: Site Reference ID/Investigator# 37363
city: Kladno
country: Czech Republic
facility: Site Reference ID/Investigator# 37283
city: Kolin
country: Czech Republic
facility: Site Reference ID/Investigator# 37382
city: Konice
country: Czech Republic
facility: Site Reference ID/Investigator# 37368
city: Konice
country: Czech Republic
facility: Site Reference ID/Investigator# 37415
city: Kralovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37272
city: Kunovice
country: Czech Republic
facility: Site Reference ID/Investigator# 42162
city: Kyjov
country: Czech Republic
facility: Site Reference ID/Investigator# 43224
city: Letohrad
country: Czech Republic
facility: Site Reference ID/Investigator# 37323
city: Liberec
country: Czech Republic
facility: Site Reference ID/Investigator# 37389
city: Litomysl
country: Czech Republic
facility: Site Reference ID/Investigator# 37416
city: Litvinov
country: Czech Republic
facility: Site Reference ID/Investigator# 37384
city: Marianske Lazne
country: Czech Republic
facility: Site Reference ID/Investigator# 37428
city: Melnik
country: Czech Republic
facility: Site Reference ID/Investigator# 37289
city: Mestec Kralove
country: Czech Republic
facility: Site Reference ID/Investigator# 37293
city: Mohelnice
country: Czech Republic
facility: Site Reference ID/Investigator# 43228
city: Mohelnice
country: Czech Republic
facility: Site Reference ID/Investigator# 43233
city: Moravska Trebova
country: Czech Republic
facility: Site Reference ID/Investigator# 43227
city: Most
country: Czech Republic
facility: Site Reference ID/Investigator# 47290
city: Neratovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37297
city: Novy Bor
country: Czech Republic
facility: Site Reference ID/Investigator# 37397
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 37303
city: Novy Jicin
country: Czech Republic
facility: Site Reference ID/Investigator# 37400
city: Obristvi
country: Czech Republic
facility: Site Reference ID/Investigator# 37399
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 37279
city: Olomouc
country: Czech Republic
facility: Site Reference ID/Investigator# 37280
city: Pardubice
country: Czech Republic
facility: Site Reference ID/Investigator# 37395
city: Plana
country: Czech Republic
facility: Site Reference ID/Investigator# 47284
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 37271
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 37273
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 37423
city: Plzen
country: Czech Republic
facility: Site Reference ID/Investigator# 37431
city: Podebrady
country: Czech Republic
facility: Site Reference ID/Investigator# 37325
city: Podebrady
country: Czech Republic
facility: Site Reference ID/Investigator# 47282
city: Prague 10
country: Czech Republic
facility: Site Reference ID/Investigator# 37375
city: Prague 14
country: Czech Republic
facility: Site Reference ID/Investigator# 37294
city: Prague 1
country: Czech Republic
facility: Site Reference ID/Investigator# 37328
city: Prague 2
country: Czech Republic
facility: Site Reference ID/Investigator# 37398
city: Prague 3
country: Czech Republic
facility: Site Reference ID/Investigator# 37410
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 37387
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 37390
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 43232
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 43365
city: Prague 4
country: Czech Republic
facility: Site Reference ID/Investigator# 43236
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 37295
city: Prague 5
country: Czech Republic
facility: Site Reference ID/Investigator# 37427
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 37419
city: Prague 6
country: Czech Republic
facility: Site Reference ID/Investigator# 37438
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 37414
city: Prague 9
country: Czech Republic
facility: Site Reference ID/Investigator# 47289
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37288
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37300
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37301
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37330
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37332
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37262
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37275
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37326
city: Prague
country: Czech Republic
facility: Site Reference ID/Investigator# 37291
city: Pribor
country: Czech Republic
facility: Site Reference ID/Investigator# 37378
city: Pribor
country: Czech Republic
facility: Site Reference ID/Investigator# 37412
city: Pribram
country: Czech Republic
facility: Site Reference ID/Investigator# 37432
city: Pribram
country: Czech Republic
facility: Site Reference ID/Investigator# 37425
city: Prostejov
country: Czech Republic
facility: Site Reference ID/Investigator# 37437
city: Prostejov
country: Czech Republic
facility: Site Reference ID/Investigator# 37430
city: Rakovnik
country: Czech Republic
facility: Site Reference ID/Investigator# 37442
city: Raspenava
country: Czech Republic
facility: Site Reference ID/Investigator# 37393
city: Roznov pod Radhostem
country: Czech Republic
facility: Site Reference ID/Investigator# 37421
city: Sadova
country: Czech Republic
facility: Site Reference ID/Investigator# 37287
city: Slapanice
country: Czech Republic
facility: Site Reference ID/Investigator# 37406
city: Steti
country: Czech Republic
facility: Site Reference ID/Investigator# 37383
city: Sumperk
country: Czech Republic
facility: Site Reference ID/Investigator# 37278
city: Sumperk
country: Czech Republic
facility: Site Reference ID/Investigator# 43223
city: Sumperk
country: Czech Republic
facility: Site Reference ID/Investigator# 43234
city: Tachov
country: Czech Republic
facility: Site Reference ID/Investigator# 37285
city: Teplice
country: Czech Republic
facility: Site Reference ID/Investigator# 37386
city: Trebic
country: Czech Republic
facility: Site Reference ID/Investigator# 37264
city: Trebic
country: Czech Republic
facility: Site Reference ID/Investigator# 37277
city: Trebon
country: Czech Republic
facility: Site Reference ID/Investigator# 43231
city: Trinec
country: Czech Republic
facility: Site Reference ID/Investigator# 37405
city: Tyn nad Vltavou
country: Czech Republic
facility: Site Reference ID/Investigator# 37265
city: Tyn
country: Czech Republic
facility: Site Reference ID/Investigator# 43366
city: Uherske Hradiste
country: Czech Republic
facility: Site Reference ID/Investigator# 37434
city: Uhersky Brod
country: Czech Republic
facility: Site Reference ID/Investigator# 37365
city: Velke Pavlovice
country: Czech Republic
facility: Site Reference ID/Investigator# 37284
city: Vlasim
country: Czech Republic
facility: Site Reference ID/Investigator# 37385
city: Zamberk
country: Czech Republic
facility: Site Reference ID/Investigator# 37322
city: Zdar nad Sazavou
country: Czech Republic
facility: Site Reference ID/Investigator# 37366
city: Zlin
country: Czech Republic
facility: Site Reference ID/Investigator# 43235
Study officials:
affiliation: Abbott Laboratories, s.r.o. (Czech Republic)
name: Adam Hloska, M.D.
role: STUDY_DIRECTOR
References: