Respiratory Tract Infections
Conditions
Keywords
Klacid SR, Clarithromycin, Respiratory tract infections, Bronchitis, Pneumonia
Brief summary
To describe the relief of symptoms, tolerability, and compliance of treatment with Klacid® sustained release (SR) at a dose of 1000 mg once daily in patients with acute tracheitis, acute tracheobronchitis, acute bronchitis, or in patients with acute exacerbation of chronic bronchitis or mild community-acquired pneumonia. This postmarketing observational study is non-interventional and is being conducted in a prospective, single-arm, single-country, multicenter format. 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 with local guidelines.
Detailed description
The postmarketing observational study is observational in nature. Its follow-up is not interventional and is left to the judgment of each physician during the observational period, which defines the survey for each patient. Follow-up of patients should enable two patient visits during this period. The screening/inclusion visit (Visit 1) will be performed when the decision for Klacid SR therapy in a daily dose of 1000 mg is made. The second visit of the patient will occur 10 - 16 days from the screening/inclusion Visit (upon physician's decision). The physician can change the numbers and time of the visits. As a result, failure to meet these suggested dates will not constitute a breach of the protocol.
Interventions
DRUGClarithromycin (Klacid SR)
Klacid SR in a dose of 1000 mg once daily
Sponsors
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men, women 18 years with 1. Acute tracheitis. 2. Acute tracheobronchitis. 3. Acute bronchitis. 4. Mild community-acquired pneumonia. 5. Acute exacerbation of chronic bronchitis. * To whom decision to initiate Klacid SR therapy in a dose of 1000 mg has been made by physician.
Exclusion criteria
* Known hypersensitivity to macrolide antibiotics * Documented renal impairment (creatinine clearance under 30 ml/min) * Concomitant therapy with the following drugs: astemizole, cisapride, pimozide, terfenadine and ergotamine or dihydroergotamine * Pregnancy * Breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Response | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups. |
| Auscultation Findings | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2. |
| Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Visit 1 (Initial visit) | Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups. |
| Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Visit 1 (Initial visit) | Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups. |
| Body Temperature | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups. |
| Cough and Its Character | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented. |
| Dyspnoea | Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician) | Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason. |
| Termination of Treatment | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The number of participants who discontinued treatment is summarized. |
| Adverse Effects | Visit 2 (10th-16th day or any other day after Visit 1 defined by physician) | The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details. |
Countries
Ukraine
Participant flow
Pre-assignment details
Of the 2822 participants enrolled, 22 were excluded from analysis for the following reasons: No baseline data (11), did not meet inclusion criteria (7), missing or inconsistent inclusion/final data (2), and no Klacid SR treatment (2). The per-protocol population consists of 2800 participants.
Participants by arm
| Arm | Count |
|---|---|
| Klacid SR The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR. | 2,800 |
| Total | 2,800 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Did not take Klacid SR | 2 |
Baseline characteristics
| Characteristic | Klacid SR |
|---|---|
| Age Continuous | 43.41 years STANDARD_DEVIATION 13.79 |
| Age, Customized 18 to 20 years | 64 Participants |
| Age, Customized 21 to 34 years | 763 Participants |
| Age, Customized 35 to 64 years | 1777 Participants |
| Age, Customized 65 to 84 years | 190 Participants |
| Age, Customized 85 years or older | 6 Participants |
| Region of Enrollment Ukraine | 2800 Participants |
| Sex/Gender, Customized Not reported | 2800 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 2,800 |
| serious Total, serious adverse events | 0 / 2,800 |
Outcome results
Primary
Auscultation Findings
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of abnormal breathing sounds such as wheezing or crackles was determined by the treating physician using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck, or abdomen) combined with their clinical judgment. Results are reported at Visit 1 and Visit 2 for all participants and by age subgroups. For participants with abnormal breathing sounds at Visit 1, resolution was noted at Visit 2.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Auscultation Findings | Visit 2: Wheezing | 184 Participants |
| Klacid SR (Total) | Auscultation Findings | b) Crackles resolved at Visit 2 | 659 Participants |
| Klacid SR (Total) | Auscultation Findings | Visit 2: Crackles | 122 Participants |
| Klacid SR (Total) | Auscultation Findings | Visit 1: Crackles | 779 Participants |
| Klacid SR (Total) | Auscultation Findings | Visit 1: Normal breath sounds | 389 Participants |
| Klacid SR (Total) | Auscultation Findings | a) Wheezing resolved at Visit 2 | 1449 Participants |
| Klacid SR (Total) | Auscultation Findings | Visit 1: Wheezing | 1632 Participants |
| Klacid SR (Total) | Auscultation Findings | Visit 2: Normal breath sounds | 2494 Participants |
| Klacid SR (Total) | Auscultation Findings | Abnormal breath sounds resolved at Visit 2 | 2108 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 1: Crackles | 708 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 1: Normal breath sounds | 378 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 2: Normal breath sounds | 2350 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 1: Wheezing | 1518 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 2: Wheezing | 153 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Visit 2: Crackles | 101 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | Abnormal breath sounds resolved at Visit 2 | 1974 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | a) Wheezing resolved at Visit 2 | 1366 Participants |
| Klacid SR (18 to 64 Years of Age) | Auscultation Findings | b) Crackles resolved at Visit 2 | 608 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 1: Wheezing | 114 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 1: Normal breath sounds | 11 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Abnormal breath sounds resolved at Visit 2 | 134 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 2: Normal breath sounds | 144 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | b) Crackles resolved at Visit 2 | 51 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 1: Crackles | 71 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 2: Wheezing | 31 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | a) Wheezing resolved at Visit 2 | 83 Participants |
| Klacid SR (65 Years of Age or Older) | Auscultation Findings | Visit 2: Crackles | 21 Participants |
Primary
Body Temperature
Body temperature was measured at Visit 1 (initial visit) and at Visit 2 (approximately 10 to 16 days later, or as defined by the treating physician). Fever was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The presence or absence of fever is reported at Visit 1 and 2 for all participants and by age subgroups.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed. Visit 2 results are shown for those who had fever at Visit 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Body Temperature | b) Fever still present at Visit 2 | 837 Participants |
| Klacid SR (Total) | Body Temperature | a) Fever resolved at Visit 2 | 1780 Participants |
| Klacid SR (Total) | Body Temperature | Visit 1: Fever present | 2617 Participants |
| Klacid SR (Total) | Body Temperature | Visit 1: No fever | 183 Participants |
| Klacid SR (18 to 64 Years of Age) | Body Temperature | Visit 1: Fever present | 2434 Participants |
| Klacid SR (18 to 64 Years of Age) | Body Temperature | a) Fever resolved at Visit 2 | 1655 Participants |
| Klacid SR (18 to 64 Years of Age) | Body Temperature | Visit 1: No fever | 170 Participants |
| Klacid SR (18 to 64 Years of Age) | Body Temperature | b) Fever still present at Visit 2 | 779 Participants |
| Klacid SR (65 Years of Age or Older) | Body Temperature | Visit 1: No fever | 13 Participants |
| Klacid SR (65 Years of Age or Older) | Body Temperature | a) Fever resolved at Visit 2 | 125 Participants |
| Klacid SR (65 Years of Age or Older) | Body Temperature | b) Fever still present at Visit 2 | 58 Participants |
| Klacid SR (65 Years of Age or Older) | Body Temperature | Visit 1: Fever present | 183 Participants |
Primary
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Chest xrays were taken at Visit 1 to determine the presence of absence of community-acquired pneumonia. Findings are presented for all participants and by age subgroups.
Time frame: Visit 1 (Initial visit)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings did not indicate pneumonia | 1742 Participants |
| Klacid SR (Total) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings indicated pneumonia | 1058 Participants |
| Klacid SR (18 to 64 Years of Age) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings did not indicate pneumonia | 1651 Participants |
| Klacid SR (18 to 64 Years of Age) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings indicated pneumonia | 953 Participants |
| Klacid SR (65 Years of Age or Older) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings did not indicate pneumonia | 91 Participants |
| Klacid SR (65 Years of Age or Older) | Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia | Findings indicated pneumonia | 105 Participants |
Primary
Cough and Its Character
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence of cough and the type of cough (productive, irritating, or both) was determined based on the clinical judgment of the treating physician. The presence or absence of cough are reported at Visits 1 and 2 for all participants and by age subgroups. For those participants who had a cough at Visit 1, the number of participants whose original type of cough subsequently resolved at Visit 2 is also presented.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Cough and Its Character | Visit 2: Had both types of cough | 1 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 1: Had productive cough | 1011 Participants |
| Klacid SR (Total) | Cough and Its Character | a) Irritating cough resolved at Visit 2 | 1438 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 1: Had both types of cough | 0 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 2: Had productive cough | 749 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 1: Did not have cough | 118 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 1: Had irritating cough | 1671 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 2: Did not have cough | 1813 Participants |
| Klacid SR (Total) | Cough and Its Character | Had any cough at Visit 1 and resolved at Visit 2 | 1712 Participants |
| Klacid SR (Total) | Cough and Its Character | Visit 2: Had irritating cough | 237 Participants |
| Klacid SR (Total) | Cough and Its Character | b) Productive cough resolved at Visit 2 | 274 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 2: Had productive cough | 682 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 1: Did not have cough | 110 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 2: Did not have cough | 1702 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 1: Had irritating cough | 1563 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 2: Had irritating cough | 220 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 1: Had productive cough | 931 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 1: Had both types of cough | 0 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Visit 2: Had both types of cough | 0 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | Had any cough at Visit 1 and resolved at Visit 2 | 1609 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | a) Irritating cough resolved at Visit 2 | 1348 Participants |
| Klacid SR (18 to 64 Years of Age) | Cough and Its Character | b) Productive cough resolved at Visit 2 | 261 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | a) Irritating cough resolved at Visit 2 | 90 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 2: Had both types of cough | 1 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 1: Had irritating cough | 108 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 1: Did not have cough | 8 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Had any cough at Visit 1 and resolved at Visit 2 | 103 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 2: Did not have cough | 111 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 2: Had productive cough | 67 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 1: Had productive cough | 80 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | b) Productive cough resolved at Visit 2 | 13 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 1: Had both types of cough | 0 Participants |
| Klacid SR (65 Years of Age or Older) | Cough and Its Character | Visit 2: Had irritating cough | 17 Participants |
Primary
Dyspnoea
Participants were evaluated at Visit 1 (initial visit) and Visit 2 (10 to 16 days later or as defined by the treating physician). The presence or absence of dyspnoea (difficulty breathing) was determined based on the clinical judgment of the treating physician and is reported for all participants and by age subgroup at Visit 1 and Visit 2. For participants with dyspnoea at Visit 1, whether the dyspnoea occurred at rest, after exercise, or both are reported. For those with dyspnoea at Visit 1, the number of participants whose original type of dyspnoea subsequently resolved at Visit 2 is noted.
Time frame: Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Dyspnoea | Visit 2: Both types of dyspnoea | 10 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 1: Dyspnoea at rest | 95 Participants |
| Klacid SR (Total) | Dyspnoea | a) After exercise dyspnoea resolved at Visit 2 | 705 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 1: Both types of dyspnoea | 1 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 2: Dyspnoea at rest | 1 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 1: No dyspnoea | 1821 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 1: Dyspnoea after exercise | 883 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 2: No dyspnoea | 2608 Participants |
| Klacid SR (Total) | Dyspnoea | Dyspnoea resolved at Visit 2 (either type) | 799 Participants |
| Klacid SR (Total) | Dyspnoea | Visit 2: Dyspnoea after exercise | 181 Participants |
| Klacid SR (Total) | Dyspnoea | b) Resting dyspnoea resolved at Visit 2 | 94 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 2: Dyspnoea at rest | 1 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 1: No dyspnoea | 1753 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 2: No dyspnoea | 2451 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 1: Dyspnoea after exercise | 766 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 2: Dyspnoea after exercise | 143 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 1: Dyspnoea at rest | 85 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 1: Both types of dyspnoea | 0 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Visit 2: Both types of dyspnoea | 9 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | Dyspnoea resolved at Visit 2 (either type) | 710 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | a) After exercise dyspnoea resolved at Visit 2 | 626 Participants |
| Klacid SR (18 to 64 Years of Age) | Dyspnoea | b) Resting dyspnoea resolved at Visit 2 | 84 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | b) Resting dyspnoea resolved at Visit 2 | 10 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 2: Both types of dyspnoea | 1 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 1: Dyspnoea after exercise | 117 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 1: No dyspnoea | 68 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | a) After exercise dyspnoea resolved at Visit 2 | 79 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Dyspnoea resolved at Visit 2 (either type) | 89 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 2: Dyspnoea at rest | 0 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 1: Dyspnoea at rest | 10 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 2: No dyspnoea | 157 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 1: Both types of dyspnoea | 1 Participants |
| Klacid SR (65 Years of Age or Older) | Dyspnoea | Visit 2: Dyspnoea after exercise | 38 Participants |
Primary
Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic)
Treating physicians were asked if Klacid SR was the first or second antibiotic prescribed to treat the participant. Results are presented for all participants and age subgroups.
Time frame: Visit 1 (Initial visit)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as second antibiotic | 377 Participants |
| Klacid SR (Total) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as first antibiotic | 2381 Participants |
| Klacid SR (Total) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as third antibiotic | 42 Participants |
| Klacid SR (18 to 64 Years of Age) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as second antibiotic | 327 Participants |
| Klacid SR (18 to 64 Years of Age) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as first antibiotic | 2237 Participants |
| Klacid SR (18 to 64 Years of Age) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as third antibiotic | 40 Participants |
| Klacid SR (65 Years of Age or Older) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as first antibiotic | 144 Participants |
| Klacid SR (65 Years of Age or Older) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as third antibiotic | 2 Participants |
| Klacid SR (65 Years of Age or Older) | Previous Prescription of Other Antibiotic (Answer Whether Klacid SR is Given as the First or as Second Antibiotic) | Klacid SR given as second antibiotic | 50 Participants |
Primary
Therapeutic Response
Therapeutic response (yes or no) was determined by the treating physician at Visit 2 based on the disappearance or significant alleviation of symptoms and regression of chest xray findings. The data are summarized by total number of participants and by age subgroups.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Therapeutic Response | Had therapeutic response to therapy | 2786 Participants |
| Klacid SR (Total) | Therapeutic Response | No therapeutic response to therapy | 14 Participants |
| Klacid SR (18 to 64 Years of Age) | Therapeutic Response | Had therapeutic response to therapy | 2592 Participants |
| Klacid SR (18 to 64 Years of Age) | Therapeutic Response | No therapeutic response to therapy | 12 Participants |
| Klacid SR (65 Years of Age or Older) | Therapeutic Response | Had therapeutic response to therapy | 194 Participants |
| Klacid SR (65 Years of Age or Older) | Therapeutic Response | No therapeutic response to therapy | 2 Participants |
Secondary
Adverse Effects
The number of participants experiencing adverse events, including serious adverse events, adverse events leading to study discontinuation, or adverse events leading to a dose reduction/temporarily stopping medication are summarized. See Reported Adverse Events for additional details.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Adverse Effects | Non-serious adverse events (AEs) | 14 Participants |
| Klacid SR (Total) | Adverse Effects | Serious AEs | 0 Participants |
| Klacid SR (Total) | Adverse Effects | Discontinued due to AEs | 1 Participants |
| Klacid SR (Total) | Adverse Effects | Dose reduced or stopped temporarily due to AEs | 0 Participants |
Secondary
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Compliance was assessed by asking physicians if participants took their medication as directed. If participants did not take their medication as directed, physicians were asked to give the reason.
Time frame: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Klacid SR (Total) | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | Dosage was followed | 2786 Participants |
| Klacid SR (Total) | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | Dosage was not followed | 14 Participants |
| Klacid SR (Total) | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | a) Dosage not followed due to adverse event | 1 Participants |
| Klacid SR (Total) | Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason) | b) Reason not reported | 13 Participants |
Secondary
Termination of Treatment
The number of participants who discontinued treatment is summarized.
Time frame: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
Population: The per-protocol population was analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Klacid SR (Total) | Termination of Treatment | 1 Participants |