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 (KLARAINE)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections
• Intervention / Treatment: Drug: Clarithromycin (Klacid SR)

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.

• Study Type: Observational
• Enrollment (Actual): 2822

Contacts and Locations

Study Locations

• Ukraine
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 29842
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 29848
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30028
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30046
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30047
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30049
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30059
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30074
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30080
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30099
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30535
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30572
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30574
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30575
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30576
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30577
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30578
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30579
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30580
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30581
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30582
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30583
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30589
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30590
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30622
  • Dnepropetrovsk, Ukraine, 49000
    • Site Reference ID/Investigator# 30623
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30050
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30051
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30054
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30057
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30060
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30066
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30071
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30073
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30573
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30584
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30585
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30600
  • Donetsk, Ukraine, 83000
    • Site Reference ID/Investigator# 30601
  • Donetsk, Ukraine, 83112
    • Site Reference ID/Investigator# 30586
  • Donetsk, Ukraine, 83112
    • Site Reference ID/Investigator# 30587
  • Donetsk, Ukraine, 83112
    • Site Reference ID/Investigator# 30588
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 29840
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30052
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30056
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30058
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30065
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30067
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30075
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30076
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30078
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30079
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30096
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30102
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30616
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30617
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30624
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30625
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30626
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30627
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30628
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30632
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 30633
  • Kharkov, Ukraine, 61000
    • Site Reference ID/Investigator# 40761
  • Kiev, Ukraine, 01000
    • Site Reference ID/Investigator# 30027
  • Kiev, Ukraine, 01004
    • Site Reference ID/Investigator# 30097
  • Kiev, Ukraine, 01004
    • Site Reference ID/Investigator# 30098
  • Kiev, Ukraine, 01004
    • Site Reference ID/Investigator# 30100
  • Kiev, Ukraine, 01004
    • Site Reference ID/Investigator# 30614
  • Kiev, Ukraine, 01004
    • Site Reference ID/Investigator# 30615
  • Kiev, Ukraine, 01030
    • Site Reference ID/Investigator# 30101
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 22142
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30553
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30554
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30555
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30556
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30557
  • Kiev, Ukraine, 01033
    • Site Reference ID/Investigator# 30558
  • Kiev, Ukraine, 02094
    • Site Reference ID/Investigator# 30061
  • Kiev, Ukraine, 03026
    • Site Reference ID/Investigator# 30533
  • Kiev, Ukraine, 03026
    • Site Reference ID/Investigator# 30534
  • Kiev, Ukraine, 03110
    • Site Reference ID/Investigator# 30591
  • Kiev, Ukraine, 03110
    • Site Reference ID/Investigator# 30592
  • Kiev, Ukraine, 03110
    • Site Reference ID/Investigator# 30593
  • Kiev, Ukraine, 03115
    • Site Reference ID/Investigator# 30069
  • Kiev, Ukraine, 04053
    • Site Reference ID/Investigator# 30537
  • Kiev, Ukraine, 04053
    • Site Reference ID/Investigator# 30538
  • Kiev, Ukraine, 04053
    • Site Reference ID/Investigator# 30539
  • Kiev, Ukraine, 04053
    • Site Reference ID/Investigator# 30540
  • Kiev, Ukraine, 04074
    • Site Reference ID/Investigator# 29839
  • Kremenchug, Ukraine, 39600
    • Site Reference ID/Investigator# 30531
  • Kremenchug, Ukraine, 39600
    • Site Reference ID/Investigator# 30532
  • Kyiv, Ukraine, 22666
    • Site Reference ID/Investigator# 40759
  • Kyiv, Ukraine, 22666
    • Site Reference ID/Investigator# 40760
  • Lugansk, Ukraine, 91000
    • Site Reference ID/Investigator# 30604
  • Lugansk, Ukraine, 91000
    • Site Reference ID/Investigator# 30605
  • Lugansk, Ukraine, 91000
    • Site Reference ID/Investigator# 30606
  • Lvov, Ukraine, 79000
    • Site Reference ID/Investigator# 30559
  • Lvov, Ukraine, 79000
    • Site Reference ID/Investigator# 30561
  • Lvov, Ukraine, 79000
    • Site Reference ID/Investigator# 30562
  • Lvov, Ukraine, 79000
    • Site Reference ID/Investigator# 30563
  • Lvov, Ukraine, 79000
    • Site Reference ID/Investigator# 30564
  • Odesa, Ukraine, 65000
    • Site Reference ID/Investigator# 29948
  • Odesa, Ukraine, 65000
    • Site Reference ID/Investigator# 30055
  • Odesa, Ukraine, 65000
    • Site Reference ID/Investigator# 30062
  • Odesa, Ukraine, 65000
    • Site Reference ID/Investigator# 30594
  • Odesa, Ukraine, 65000
    • Site Reference ID/Investigator# 30595
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 29838
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30044
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30045
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30063
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30126
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30618
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30619
  • Poltava, Ukraine, 36000
    • Site Reference ID/Investigator# 30620
  • Poltava, Ukraine, Poltava
    • Site Reference ID/Investigator# 30621
  • Simferopol', Ukraine, 95000
    • Site Reference ID/Investigator# 30072
  • Vynnytsya, Ukraine, 21000
    • Site Reference ID/Investigator# 30629
  • Vynnytsya, Ukraine, 21000
    • Site Reference ID/Investigator# 30631
  • Yevpatoriya, Ukraine, 97400
    • Site Reference ID/Investigator# 30190
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30068
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30565
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30566
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30567
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30568
  • Zaporizhya, Ukraine, 69000
    • Site Reference ID/Investigator# 30570

Participation Criteria

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

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute upper respiratory tract diseases, bronchitis, pneumonia	Drug: Clarithromycin (Klacid SR); Klacid SR in a dose of 1000 mg once daily; Other Names: Klaricid; Clarithromycin; Biaxin; Klacid; Biclar; Abbotic; Zeclar; Klacid SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Temperature	Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Cough and Its Character	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Dyspnoea	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Auscultation Findings	Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.	Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia	Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.	Visit 1 (Initial visit)
Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)	Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.	Visit 1 (Initial visit)
Therapeutic Response	Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects	The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)	Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.	Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
Termination of Treatment	The number of participants who discontinued treatment is summarized.	Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Irina Magdik, MD, Abbott Laboratories S.A., Ukraine

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: February 28, 2010
• First Submitted That Met QC Criteria: March 29, 2010
• First Posted (ESTIMATE): March 30, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2011
• Last Update Submitted That Met QC Criteria: June 29, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Pneumonia; Clarithromycin; Bronchitis; Respiratory tract infections; Klacid SR
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Tracheal Diseases; Pneumonia; Respiratory Tract Infections; Bronchitis; Bronchitis, Chronic; Tracheitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: P11-979