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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 3,130
- Locations
- 135
- Primary Endpoint
- Disappearance or Significant Alleviation of Symptoms
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
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 Outcomes
- Body Temperature(Day 0, Day 8-16)
- Bacteriological Investigation (if Available)(Day 0)
- Cough and Its Character(Day 0, Day 8-16)
- Dyspnea and Its Type(Day 0, Day 8-16)
- Auscultation(Day 0, Day 8-16)
- Chest X-ray in Case of Community-Acquired Pneumonia (CAP)(Day 0)
- Study Drug Given as the First, Second or Third Antimicrobial Treatment(Day 0)
- Compliance(Day 8 - 16)
- Termination of Treatment Due to Noncompliance(Day 8 - 16)