Clinical trial NCT01095978: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Infections
Keywords: Klacid SR
Clarithromycin
Respiratory tract infections
Bronchitis
Pneumonia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-30
Enrollment: 2822
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: Consulting rooms of general practitioners, pulmonologists, and allergologists and centers with experience in the treatment of patients with acute upper respiratory tract diseases, acute bronchitis or acute exacerbation of chronic bronchitis or mild community-acquired pneumonia.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Temperature
timeFrame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
measure: Cough and Its Character
timeFrame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
measure: Dyspnoea
timeFrame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
measure: Auscultation Findings
timeFrame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
measure: Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
timeFrame: Visit 1 (Initial visit)
measure: Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)
timeFrame: Visit 1 (Initial visit)
measure: Therapeutic Response
timeFrame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Secondary outcomes:
measure: Adverse Effects
timeFrame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
measure: Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
timeFrame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
measure: Termination of Treatment
timeFrame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Other outcomes:
Locations:
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 29842
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 29848
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30028
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30046
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30047
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30049
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30059
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30074
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30080
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30099
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30535
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30572
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30574
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30575
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30576
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30577
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30578
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30579
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30580
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30581
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30582
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30583
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30589
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30590
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30622
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 30623
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30050
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30051
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30054
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30057
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30060
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30066
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30071
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30073
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30573
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30584
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30585
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30600
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30601
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30586
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30587
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 30588
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 29840
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30052
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30056
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30058
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30065
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30067
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30075
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30076
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30078
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30079
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30096
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30102
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30616
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30617
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30624
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30625
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30626
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30627
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30628
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30632
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 30633
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 40761
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30027
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30097
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30098
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30100
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30614
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30615
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30101
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 22142
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30553
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30554
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30555
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30556
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30557
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30558
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30061
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30533
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30534
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30591
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30592
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30593
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30069
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30537
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30538
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30539
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 30540
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 29839
city: Kremenchug
country: Ukraine
facility: Site Reference ID/Investigator# 30531
city: Kremenchug
country: Ukraine
facility: Site Reference ID/Investigator# 30532
city: Kyiv
country: Ukraine
facility: Site Reference ID/Investigator# 40759
city: Kyiv
country: Ukraine
facility: Site Reference ID/Investigator# 40760
city: Lugansk
country: Ukraine
facility: Site Reference ID/Investigator# 30604
city: Lugansk
country: Ukraine
facility: Site Reference ID/Investigator# 30605
city: Lugansk
country: Ukraine
facility: Site Reference ID/Investigator# 30606
city: Lvov
country: Ukraine
facility: Site Reference ID/Investigator# 30559
city: Lvov
country: Ukraine
facility: Site Reference ID/Investigator# 30561
city: Lvov
country: Ukraine
facility: Site Reference ID/Investigator# 30562
city: Lvov
country: Ukraine
facility: Site Reference ID/Investigator# 30563
city: Lvov
country: Ukraine
facility: Site Reference ID/Investigator# 30564
city: Odesa
country: Ukraine
facility: Site Reference ID/Investigator# 29948
city: Odesa
country: Ukraine
facility: Site Reference ID/Investigator# 30055
city: Odesa
country: Ukraine
facility: Site Reference ID/Investigator# 30062
city: Odesa
country: Ukraine
facility: Site Reference ID/Investigator# 30594
city: Odesa
country: Ukraine
facility: Site Reference ID/Investigator# 30595
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 29838
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30044
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30045
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30063
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30126
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30618
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30619
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30620
city: Poltava
country: Ukraine
facility: Site Reference ID/Investigator# 30621
city: Simferopol'
country: Ukraine
facility: Site Reference ID/Investigator# 30072
city: Vynnytsya
country: Ukraine
facility: Site Reference ID/Investigator# 30629
city: Vynnytsya
country: Ukraine
facility: Site Reference ID/Investigator# 30631
city: Yevpatoriya
country: Ukraine
facility: Site Reference ID/Investigator# 30190
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30068
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30565
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30566
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30567
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30568
city: Zaporizhya
country: Ukraine
facility: Site Reference ID/Investigator# 30570
Study officials:
affiliation: Abbott Laboratories S.A., Ukraine
name: Irina Magdik, MD
role: STUDY_DIRECTOR
References: