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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01095978
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : June 15, 2011
Last Update Posted : July 11, 2011
Sponsor:
Information provided by:
Abbott

Tracking Information
First Submitted Date February 28, 2010
First Posted Date March 30, 2010
Results First Submitted Date May 17, 2011
Results First Posted Date June 15, 2011
Last Update Posted Date July 11, 2011
Study Start Date August 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2011)
  • Body Temperature [ Time Frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
  • Cough and Its Character [ Time Frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
  • Dyspnoea [ Time Frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
  • Auscultation Findings [ Time Frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
  • Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia [ Time Frame: Visit 1 (Initial visit) ]
    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.
  • Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) [ Time Frame: Visit 1 (Initial visit) ]
    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.
  • Therapeutic Response [ Time Frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
Original Primary Outcome Measures
 (submitted: March 29, 2010)
  • Body Temperature [ Time Frame: Visit 1 (Inclusion visit), Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Cough and Its Character [ Time Frame: Visit 1 (Inclusion visit), Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Dyspnoea [ Time Frame: Visit 1 (Inclusion visit), Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Auscultation Findings [ Time Frame: Visit 1 (Inclusion visit), Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Chest X-ray - necessary for verification of the diagnosis of pneumonia , community acquired pneumonia (CAP) [ Time Frame: Visit 1 (Inclusion visit) ]
  • Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) [ Time Frame: Visit 1 (Inclusion visit) ]
  • Therapeutic Response [ Time Frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
Change History
Current Secondary Outcome Measures
 (submitted: May 17, 2011)
  • Adverse Effects [ Time Frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    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.
  • Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) [ Time Frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
    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.
  • Termination of Treatment [ Time Frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ]
    The number of participants who discontinued treatment is summarized.
Original Secondary Outcome Measures
 (submitted: March 29, 2010)
  • Adverse Effects [ Time Frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) [ Time Frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
  • Termination of Treatment [ Time Frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.

Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Respiratory Tract Infections
Intervention Drug: Clarithromycin (Klacid SR)
Klacid SR in a dose of 1000 mg once daily
Other Names:
  • Biaxin
  • Abbotic
  • Biclar
  • Klacid
  • Klaricid
  • Zeclar
  • Clarithromycin
  • Klacid SR
Study Groups/Cohorts Acute upper respiratory tract diseases, bronchitis, pneumonia
Intervention: Drug: Clarithromycin (Klacid SR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 31, 2011)
2822
Original Estimated Enrollment
 (submitted: March 29, 2010)
3000
Actual Study Completion Date May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT01095978
Other Study ID Numbers P11-979
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Irina Magdik, Medical Director, Abbott Laboratories S.A., Ukraine
Study Sponsor Abbott
Collaborators Not Provided
Investigators
Study Director: Irina Magdik, MD Abbott Laboratories S.A., Ukraine
PRS Account Abbott
Verification Date June 2011