Trial record 4 of 421 for:    bronchitis

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)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01095978
First received: February 28, 2010
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Respiratory Tract Infections
Drug: Clarithromycin (Klacid SR)

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Body Temperature [ Time Frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Adverse Effects [ Time Frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The number of participants who discontinued treatment is summarized.


Enrollment: 2822
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Acute upper respiratory tract diseases, bronchitis, pneumonia 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01095978

  Show 126 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Irina Magdik, MD Abbott Laboratories S.A., Ukraine
  More Information

No publications provided

Responsible Party: Irina Magdik, Medical Director, Abbott Laboratories S.A., Ukraine
ClinicalTrials.gov Identifier: NCT01095978     History of Changes
Other Study ID Numbers: P11-979
Study First Received: February 28, 2010
Results First Received: May 17, 2011
Last Updated: June 29, 2011
Health Authority: Ukraine: State Pharmacological Center - Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Abbott:
Klacid SR
Clarithromycin
Respiratory tract infections
Bronchitis
Pneumonia

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Acute Disease
Pneumonia
Respiratory Tract Infections
Tracheitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Infection
Tracheal Diseases
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014