Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01108185
First received: April 20, 2010
Last updated: September 9, 2011
Last verified: September 2011
  Purpose

The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).


Condition
Tracheitis
Tracheobronchitis
Bronchitis
Chronic Bronchitis
Community-acquired Pneumonia

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 or Mild Community-acquired Bronchopneumonia in Common Clinical Practice in the Slovak Republic

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Compliance (Was the Dosage Followed - Yes, no) [ Time Frame: Day 10 - 16 ] [ Designated as safety issue: No ]
    Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.

  • The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events [ Time Frame: Day 0 through Days 10 - 16 ] [ Designated as safety issue: No ]
    The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.


Secondary Outcome Measures:
  • Body Temperature [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.

  • Body Temperature [ Time Frame: Day 10 - 16 ] [ Designated as safety issue: No ]
    Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.

  • Cough and Its Character [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.

  • Cough and Its Character [ Time Frame: Day 10 - 16 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.

  • Dyspnoea [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.

  • Dyspnoea [ Time Frame: Day 10 - 16 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.

  • Auscultation [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.

  • Auscultation [ Time Frame: Day 10 - 16 ] [ Designated as safety issue: No ]
    Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.


Enrollment: 3181
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute Respiratory Infections
Slovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).

Detailed Description:

This PMOS will be conducted in a prospective, open-label, 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 lower respiratory tract infection, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a PMOS, 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. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.

Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.

  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

Patients included in this PMOS will be those with acute tracheitis, acute tracheobronchitis, acute bronchitis, mild CAP and acute exacerbation of chronic bronchitis with infectious etiology caused probably by an atypical agent.

Criteria

Inclusion Criteria:

  • Men, women at least 18 years old

    • with acute tracheitis,
    • acute tracheobronchitis,
    • acute bronchitis,
    • mild community-acquired pneumonia or
    • acute exacerbation of chronic bronchitis

Exclusion Criteria:

  • 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
  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: NCT01108185

  Show 158 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Adam Hloska, M.D. Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01108185     History of Changes
Other Study ID Numbers: P12-060
Study First Received: April 20, 2010
Results First Received: July 26, 2011
Last Updated: September 9, 2011
Health Authority: Slovak Republic: Ethics Committee

Keywords provided by Abbott:
treatment with Klacid®SR
tracheitis
tracheobronchitis
bronchitis
chronic bronchitis
community-acquired pneumonia

Additional relevant MeSH terms:
Acute Disease
Bronchitis
Bronchitis, Chronic
Pneumonia
Respiratory Tract Infections
Tracheitis
Bronchial Diseases
Disease Attributes
Infection
Lung Diseases
Lung Diseases, Obstructive
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tracheal Diseases

ClinicalTrials.gov processed this record on October 23, 2014