Trial Outcomes & Findings for Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine (NCT NCT01095978)
NCT ID: NCT01095978
Last Updated: 2011-07-11
Results Overview
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.
COMPLETED
2822 participants
Visit 1 (initial visit), Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
2011-07-11
Participant Flow
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.
Participant milestones
| Measure |
Klacid SR
Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
|
|---|---|
|
Overall Study
STARTED
|
2822
|
|
Overall Study
COMPLETED
|
2819
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Klacid SR
Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
|
|---|---|
|
Overall Study
Did not take Klacid SR
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in Ukraine
Baseline characteristics by cohort
| Measure |
Klacid SR
n=2800 Participants
The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
|---|---|
|
Age Continuous
|
43.41 years
STANDARD_DEVIATION 13.79 • n=5 Participants
|
|
Age, Customized
18 to 20 years
|
64 Participants
n=5 Participants
|
|
Age, Customized
21 to 34 years
|
763 Participants
n=5 Participants
|
|
Age, Customized
35 to 64 years
|
1777 Participants
n=5 Participants
|
|
Age, Customized
65 to 84 years
|
190 Participants
n=5 Participants
|
|
Age, Customized
85 years or older
|
6 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not reported
|
2800 Participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
2800 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Body Temperature
Visit 1: No fever
|
183 Participants
|
170 Participants
|
13 Participants
|
|
Body Temperature
a) Fever resolved at Visit 2
|
1780 Participants
|
1655 Participants
|
125 Participants
|
|
Body Temperature
b) Fever still present at Visit 2
|
837 Participants
|
779 Participants
|
58 Participants
|
|
Body Temperature
Visit 1: Fever present
|
2617 Participants
|
2434 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Cough and Its Character
Visit 1: Did not have cough
|
118 Participants
|
110 Participants
|
8 Participants
|
|
Cough and Its Character
Visit 2: Did not have cough
|
1813 Participants
|
1702 Participants
|
111 Participants
|
|
Cough and Its Character
Visit 1: Had irritating cough
|
1671 Participants
|
1563 Participants
|
108 Participants
|
|
Cough and Its Character
Visit 2: Had irritating cough
|
237 Participants
|
220 Participants
|
17 Participants
|
|
Cough and Its Character
Visit 1: Had productive cough
|
1011 Participants
|
931 Participants
|
80 Participants
|
|
Cough and Its Character
Visit 2: Had productive cough
|
749 Participants
|
682 Participants
|
67 Participants
|
|
Cough and Its Character
Visit 1: Had both types of cough
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cough and Its Character
Visit 2: Had both types of cough
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cough and Its Character
Had any cough at Visit 1 and resolved at Visit 2
|
1712 Participants
|
1609 Participants
|
103 Participants
|
|
Cough and Its Character
b) Productive cough resolved at Visit 2
|
274 Participants
|
261 Participants
|
13 Participants
|
|
Cough and Its Character
a) Irritating cough resolved at Visit 2
|
1438 Participants
|
1348 Participants
|
90 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Dyspnoea
Visit 2: No dyspnoea
|
2608 Participants
|
2451 Participants
|
157 Participants
|
|
Dyspnoea
Visit 2: Dyspnoea after exercise
|
181 Participants
|
143 Participants
|
38 Participants
|
|
Dyspnoea
Visit 1: Dyspnoea at rest
|
95 Participants
|
85 Participants
|
10 Participants
|
|
Dyspnoea
Visit 2: Dyspnoea at rest
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Dyspnoea
Visit 1: Both types of dyspnoea
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Dyspnoea
Visit 2: Both types of dyspnoea
|
10 Participants
|
9 Participants
|
1 Participants
|
|
Dyspnoea
Dyspnoea resolved at Visit 2 (either type)
|
799 Participants
|
710 Participants
|
89 Participants
|
|
Dyspnoea
a) After exercise dyspnoea resolved at Visit 2
|
705 Participants
|
626 Participants
|
79 Participants
|
|
Dyspnoea
b) Resting dyspnoea resolved at Visit 2
|
94 Participants
|
84 Participants
|
10 Participants
|
|
Dyspnoea
Visit 1: No dyspnoea
|
1821 Participants
|
1753 Participants
|
68 Participants
|
|
Dyspnoea
Visit 1: Dyspnoea after exercise
|
883 Participants
|
766 Participants
|
117 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Auscultation Findings
Visit 1: Normal breath sounds
|
389 Participants
|
378 Participants
|
11 Participants
|
|
Auscultation Findings
Visit 1: Wheezing
|
1632 Participants
|
1518 Participants
|
114 Participants
|
|
Auscultation Findings
Visit 2: Wheezing
|
184 Participants
|
153 Participants
|
31 Participants
|
|
Auscultation Findings
Visit 1: Crackles
|
779 Participants
|
708 Participants
|
71 Participants
|
|
Auscultation Findings
Visit 2: Crackles
|
122 Participants
|
101 Participants
|
21 Participants
|
|
Auscultation Findings
Abnormal breath sounds resolved at Visit 2
|
2108 Participants
|
1974 Participants
|
134 Participants
|
|
Auscultation Findings
a) Wheezing resolved at Visit 2
|
1449 Participants
|
1366 Participants
|
83 Participants
|
|
Auscultation Findings
b) Crackles resolved at Visit 2
|
659 Participants
|
608 Participants
|
51 Participants
|
|
Auscultation Findings
Visit 2: Normal breath sounds
|
2494 Participants
|
2350 Participants
|
144 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Initial visit)Population: The per-protocol population was analyzed.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Findings did not indicate pneumonia
|
1742 Participants
|
1651 Participants
|
91 Participants
|
|
Chest Xray - Necessary for Verification of the Diagnosis of Pneumonia , Community-acquired Pneumonia
Findings indicated pneumonia
|
1058 Participants
|
953 Participants
|
105 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Initial visit)Population: The per-protocol population was analyzed.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 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
|
2381 Participants
|
2237 Participants
|
144 Participants
|
|
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
|
327 Participants
|
50 Participants
|
|
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
|
40 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)Population: The per-protocol population was analyzed.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
n=2604 Participants
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
n=196 Participants
Participants 65 years of age or older.
|
|---|---|---|---|
|
Therapeutic Response
No therapeutic response to therapy
|
14 Participants
|
12 Participants
|
2 Participants
|
|
Therapeutic Response
Had therapeutic response to therapy
|
2786 Participants
|
2592 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)Population: The per-protocol population was analyzed.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
Participants 65 years of age or older.
|
|---|---|---|---|
|
Adverse Effects
Serious AEs
|
0 Participants
|
—
|
—
|
|
Adverse Effects
Non-serious adverse events (AEs)
|
14 Participants
|
—
|
—
|
|
Adverse Effects
Discontinued due to AEs
|
1 Participants
|
—
|
—
|
|
Adverse Effects
Dose reduced or stopped temporarily due to AEs
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 2 (10th-16th day or any other day after Inclusion Visit defined by physician)Population: The per-protocol population was analyzed.
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.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
Participants 65 years of age or older.
|
|---|---|---|---|
|
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Dosage was followed
|
2786 Participants
|
—
|
—
|
|
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
Dosage was not followed
|
14 Participants
|
—
|
—
|
|
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
|
—
|
—
|
|
Compliance (Was the Dosage and Duration of Therapy Followed or Not; if Not - Explain the Reason)
b) Reason not reported
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)Population: The per-protocol population was analyzed.
The number of participants who discontinued treatment is summarized.
Outcome measures
| Measure |
Klacid SR (Total)
n=2800 Participants
All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
|
Klacid SR (18 to 64 Years of Age)
Participants 18 to 64 years of age.
|
Klacid SR (65 Years of Age or Older)
Participants 65 years of age or older.
|
|---|---|---|---|
|
Termination of Treatment
|
1 Participants
|
—
|
—
|
Adverse Events
Klacid SR
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Klacid SR
n=2800 participants at risk
Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
0.25%
7/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Nervous system disorders
Dysgeusia
|
0.21%
6/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.11%
3/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Disbacteriosis
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Alanine aminotransferase increased
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Aspartate aminotransferase increased
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.04%
1/2800 • Adverse events were collected through Visit 2 (10th-16th day or any other day after Visit 1 defined by physician)
The safety analysis set was used for the analysis of safety and tolerability. The safety population consisted of all subjects who received at least one dose of Klacid SR and had final visit documentation (2800 participants).
|
Additional Information
Global Medical Services
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
- Publication restrictions are in place
Restriction type: OTHER