Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR
This study has been completed.
Sponsor:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01130883
First received: May 6, 2010
Last updated: September 8, 2011
Last verified: September 2011
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Purpose
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 |
|---|
|
Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-Acquired Pneumonia (CAP) |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Disappearance or Significant Alleviation of Symptoms [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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:
- Body Temperature [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
- Bacteriological Investigation (if Available) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]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.
- Cough and Its Character [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
- Dyspnea and Its Type [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
- Auscultation [ Time Frame: Day 0, Day 8-16 ] [ Designated as safety issue: No ]Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
- Chest X-ray in Case of Community-Acquired Pneumonia (CAP) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]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.
- Study Drug Given as the First, Second or Third Antimicrobial Treatment [ Time Frame: Day 0 ] [ Designated as safety issue: No ]Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
- Compliance [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
- Termination of Treatment Due to Noncompliance [ Time Frame: Day 8 - 16 ] [ Designated as safety issue: No ]Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
| Enrollment: | 3130 |
| Study Start Date: | February 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01130883
Show 135 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130883
Show 135 Study Locations
Sponsors and Collaborators
Abbott
Investigators
| Study Director: | Adam Hloska, M.D. | Abbott Laboratories, s.r.o. (Czech Republic) |
More Information
| Responsible Party: | Abbott |
| ClinicalTrials.gov Identifier: | NCT01130883 History of Changes |
| Other Study ID Numbers: | P12-109 |
| Study First Received: | May 6, 2010 |
| Results First Received: | July 25, 2011 |
| Last Updated: | September 8, 2011 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
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 |
ClinicalTrials.gov processed this record on September 28, 2016