Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

Study Description

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Brief Summary:

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, 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 acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, 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. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.

Condition or disease
Tracheitis; Tracheobronchitis; Bronchitis; Chronic Bronchitis; Community-Acquired Pneumonia (CAP)

Detailed Description:

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Study Design

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Study Type :	Observational
Actual Enrollment :	3130 participants
Time Perspective:	Prospective
Official Title:	Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic
Study Start Date :	February 2010
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	July 2010

Groups and Cohorts

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Group/Cohort

Respiratory Infections; Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).

Outcome Measures

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Primary Outcome Measures :

1. Disappearance or Significant Alleviation of Symptoms [ Time Frame: Day 8 - 16 ]
   Overall therapeutic response, "yes" or "no" was determined by the physician based on subjective response regarding disappearance or significant alleviation of symptoms following treatment. The physician also considered objective findings such as auscultation and or chest X-ray results (if available) when determining overall therapeutic response.
2. Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) [ Time Frame: Day 0, Day 8 - 16 ]
   Auscultation findings (abnormal breath sounds) were assessed at the initial visit (Day 0) and the second visit (Day 8 -16) by the physician. "Regression of chest X-ray findings" were not recorded as it is not part of routine clinical practice to confirm X-ray regression after the participant has clinically recovered from Community-Acquired Pneumonia (CAP).

Secondary Outcome Measures :

1. Body Temperature [ Time Frame: Day 0, Day 8-16 ]
   Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
2. Bacteriological Investigation (if Available) [ Time Frame: Day 0 ]
   The type of agent present in the infection was assessed using bacteriological investigation. Occurrence of the most common agents was reported. Participants may have had more than one pathogen present. Test results were not available prior to enrollment but were reported during the study.
3. Cough and Its Character [ Time Frame: Day 0, Day 8-16 ]
   Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
4. Dyspnea and Its Type [ Time Frame: Day 0, Day 8-16 ]
   Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
5. Auscultation [ Time Frame: Day 0, Day 8-16 ]
   Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
6. Chest X-ray in Case of Community-Acquired Pneumonia (CAP) [ Time Frame: Day 0 ]
   Number of participants in which X-ray findings were suggestive of pneumonia. In participants where the physician suspected CAP, a chest X-ray was performed and reviewed to determine whether findings were indicative of pneumonia.
7. Study Drug Given as the First, Second or Third Antimicrobial Treatment [ Time Frame: Day 0 ]
   Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
8. Compliance [ Time Frame: Day 8 - 16 ]
   Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
9. Termination of Treatment Due to Noncompliance [ Time Frame: Day 8 - 16 ]
   Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• Men, women at least 18 years old.
• Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.

• Patients:

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

Exclusion Criteria:

• Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.
• 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 135 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:	Adam Hloska, M.D.	Abbott Laboratories, s.r.o. (Czech Republic)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01130883 History of Changes
Other Study ID Numbers:	P12-109
First Posted:	May 26, 2010
Results First Posted:	August 23, 2011
Last Update Posted:	September 12, 2011
Last Verified:	September 2011

Keywords provided by Abbott:

acute tracheitis; acute tracheobronchitis or acute bronchitis; acute exacerbation of chronic bronchitis; mild community-acquired pneumonia

Additional relevant MeSH terms:

Bronchitis; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive; Pneumonia; Acute Disease; Tracheitis; Lung Diseases	Respiratory Tract Diseases; Respiratory Tract Infections; Bronchial Diseases; Lung Diseases, Obstructive; Disease Attributes; Pathologic Processes; Tracheal Diseases