Bronchitis, Chronic Bronchitis, Community-Acquired Pneumonia (CAP), Tracheitis, Tracheobronchitis
Conditions
Keywords
acute tracheitis, acute tracheobronchitis or acute bronchitis, acute exacerbation of chronic bronchitis, mild community-acquired pneumonia
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.
Interventions
None listed
Sponsors
Abbott
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disappearance or Significant Alleviation of Symptoms | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Cough and Its Character | 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) |
| Dyspnea and Its Type | Day 0, Day 8-16 | Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported). |
| Auscultation | Day 0, Day 8-16 | Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported). |
| Body Temperature | Day 0, Day 8-16 | Number of participants in which body temperature was increased (temperature above 37 degrees Celsius). |
| Study Drug Given as the First, Second or Third Antimicrobial Treatment | Day 0 | Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent. |
| Compliance | Day 8 - 16 | Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study. |
| Termination of Treatment Due to Noncompliance | Day 8 - 16 | Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen. |
| Chest X-ray in Case of Community-Acquired Pneumonia (CAP) | 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. |
| Bacteriological Investigation (if Available) | 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. |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Klacid SR Treatment Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants 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 dose administered within this study. | 3,130 |
| Total | 3,130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Patient Noncompliance | 6 |
| Overall Study | Reason Unknown | 1 |
Baseline characteristics
| Characteristic | Klacid SR Treatment |
|---|---|
| Age, Customized 18 to 29 years of age | 281 participants |
| Age, Customized 30 to 39 years of age | 544 participants |
| Age, Customized 40 to 49 years of age | 589 participants |
| Age, Customized 50 to 59 years of age | 680 participants |
| Age, Customized 60 to 69 years of age | 630 participants |
| Age, Customized 70 to 79 years of age | 305 participants |
| Age, Customized 80 to 89 years of age | 92 participants |
| Age, Customized 90 years of age and older | 7 participants |
| Age, Customized less than 18 years of age | 2 participants |
| Region of Enrollment Czech Republic | 3130 participants |
| Sex/Gender, Customized | 3130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 3,128 |
| serious Total, serious adverse events | 2 / 3,128 |
Outcome results
Primary
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
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).
Time frame: Day 0, Day 8 - 16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Initial Visit - Auscultation Normal | 956 participants |
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Initial Visit - Auscultation Abnormal | 2146 participants |
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Initial Visit - Findings Not Reported | 26 participants |
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Second Visit - Auscultation Normal | 2768 participants |
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Second Visit - Auscultation Abnormal | 247 participants |
| Klacid SR Treatment | Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) | Second Visit - Findings Not Reported | 113 participants |
Primary
Disappearance or Significant Alleviation of Symptoms
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.
Time frame: Day 8 - 16
Population: A total of 3130 participants were enrolled into the study and 3128 were included in the analysis. Two participants were excluded from the analysis as they did not meet entry criteria (2 participants were less than 18 years of age).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Klacid SR Treatment | Disappearance or Significant Alleviation of Symptoms | 3109 Participants |
Secondary
Auscultation
Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
Time frame: Day 0, Day 8-16
Population: Of the 3128 participants included in the analysis, auscultation findings were not reported for 38 participants at the initial visit and 116 participants at the final visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Auscultation | Initial Visit - Abnormal Auscultaton findings | 2146 Participants |
| Klacid SR Treatment | Auscultation | a) Wheezing | 1577 Participants |
| Klacid SR Treatment | Auscultation | b) Crackles | 408 Participants |
| Klacid SR Treatment | Auscultation | c) Both wheezing and crackles | 145 Participants |
| Klacid SR Treatment | Auscultation | d) Not reported | 16 Participants |
| Klacid SR Treatment | Auscultation | Second Visit -Abnormal Auscultation findings | 247 Participants |
| Klacid SR Treatment | Auscultation | a) Wheezing- | 187 Participants |
| Klacid SR Treatment | Auscultation | b) Crackles- | 54 Participants |
| Klacid SR Treatment | Auscultation | c) Both wheezing and crackles- | 4 Participants |
| Klacid SR Treatment | Auscultation | d) Not reported- | 2 Participants |
Secondary
Bacteriological Investigation (if Available)
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.
Time frame: Day 0
Population: Of the 3128 participants included in the analysis, 225 participants had bacteriological investigations conducted at the Initial visit (Day 0). Some participants had more than one finding.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Haemophilus Influenzae | 48 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Streptococcus pneumoniae | 38 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Chlamydia pneumoniae | 34 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Mycoplasma pneumoniae | 14 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Haemophilus parainfluenzae | 13 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Klebsiella pneumoniae | 12 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Haemophilus species | 10 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Staphylococcus aureus | 5 participants |
| Klacid SR Treatment | Bacteriological Investigation (if Available) | Branhamella catarrhalis | 5 participants |
Secondary
Body Temperature
Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
Time frame: Day 0, Day 8-16
Population: Of the 3128 participants included in the analysis, body temperature was not reported for 6 participants at the Initial visit, and 14 participants at the Second visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Body Temperature | Second Visit - Temperature not reported | 14 Participants |
| Klacid SR Treatment | Body Temperature | Initial Visit - Temperature above 37 degrees C | 2252 Participants |
| Klacid SR Treatment | Body Temperature | Initial Visit - Temperature not above 37 degrees C | 870 Participants |
| Klacid SR Treatment | Body Temperature | Initial Visit - Temperature not reported | 6 Participants |
| Klacid SR Treatment | Body Temperature | Second Visit - Temperature above 37 degrees C | 101 Participants |
| Klacid SR Treatment | Body Temperature | Second Visit - Temperature not above 37 degrees C | 3013 Participants |
Secondary
Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
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.
Time frame: Day 0
Population: Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Chest X-ray in Case of Community-Acquired Pneumonia (CAP) | Findings indicative of pneumonia | 276 Participants |
| Klacid SR Treatment | Chest X-ray in Case of Community-Acquired Pneumonia (CAP) | Findings not indicative of pneumonia | 18 Participants |
Secondary
Compliance
Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
Time frame: Day 8 - 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Klacid SR Treatment | Compliance | 3122 Participants |
Secondary
Cough and Its Character
Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
Time frame: Day 0, Day 8-16
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Klacid SR Treatment | Cough and Its Character | Initial Visit - Presence of cough | 2942 Participants |
| Klacid SR Treatment | Cough and Its Character | a) Irritating cough | 1601 Participants |
| Klacid SR Treatment | Cough and Its Character | b) Productive cough | 1177 Participants |
| Klacid SR Treatment | Cough and Its Character | c) Both irritating and productive | 157 Participants |
| Klacid SR Treatment | Cough and Its Character | d) Not Reported | 7 Participants |
| Klacid SR Treatment | Cough and Its Character | Initial Visit -Cough not present | 186 Participants |
| Klacid SR Treatment | Cough and Its Character | Second Visit -Presence of cough | 556 Participants |
| Klacid SR Treatment | Cough and Its Character | a) Irritating cough. | 187 Participants |
| Klacid SR Treatment | Cough and Its Character | b) Productive cough. | 351 Participants |
| Klacid SR Treatment | Cough and Its Character | c) Both irritating and productive. | 16 Participants |
| Klacid SR Treatment | Cough and Its Character | d) Not Reported. | 2 Participants |
| Klacid SR Treatment | Cough and Its Character | Second Visit -Cough not present | 2572 Participants |
Secondary
Dyspnea and Its Type
Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
Time frame: Day 0, Day 8-16
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Dyspnea and Its Type | Initial Visit - Presence of dyspnea | 1091 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | a) Exertional | 794 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | b) Resting | 235 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | c) Both exertional and resting | 60 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | d) Type of dyspnea not reported | 2 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | Initial Visit - Dyspnea not present | 2037 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | Second Visit - Presence of dyspnea | 262 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | a) Exertional- | 234 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | b) Resting- | 17 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | c) Both exertional and resting- | 9 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | d) Type of dyspnea not reported- | 2 Participants |
| Klacid SR Treatment | Dyspnea and Its Type | Second Visit -Dyspnea not present | 2866 Participants |
Secondary
Study Drug Given as the First, Second or Third Antimicrobial Treatment
Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Time frame: Day 0
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR Treatment | Study Drug Given as the First, Second or Third Antimicrobial Treatment | Klacid SR as first antimicrobial treatment | 2910 Participants |
| Klacid SR Treatment | Study Drug Given as the First, Second or Third Antimicrobial Treatment | Klacid SR as second antimicrobial treatment | 216 Participants |
| Klacid SR Treatment | Study Drug Given as the First, Second or Third Antimicrobial Treatment | Klacid SR as third antimicrobial treatment | 2 Participants |
Secondary
Termination of Treatment Due to Noncompliance
Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
Time frame: Day 8 - 16
Population: A total of 3128 participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Klacid SR Treatment | Termination of Treatment Due to Noncompliance | 6 Participants |