Trial Outcomes & Findings for Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR (NCT NCT01130883)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

3130 participants

Primary outcome timeframe

Day 8 - 16

Results posted on

2025-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3130
Overall Study Participants Analyzed	3128
Overall Study COMPLETED	3120
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Patient Noncompliance	6
Overall Study Reason Unknown	1
Overall Study Adverse Event	3

Baseline Characteristics

Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Klacid SR Treatment n=3130 Participants 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.
Age, Customized less than 18 years of age	2 participants n=99 Participants
Age, Customized 18 to 29 years of age	281 participants n=99 Participants
Age, Customized 30 to 39 years of age	544 participants n=99 Participants
Age, Customized 40 to 49 years of age	589 participants n=99 Participants
Age, Customized 50 to 59 years of age	680 participants n=99 Participants
Age, Customized 60 to 69 years of age	630 participants n=99 Participants
Age, Customized 70 to 79 years of age	305 participants n=99 Participants
Age, Customized 80 to 89 years of age	92 participants n=99 Participants
Age, Customized 90 years of age and older	7 participants n=99 Participants
Sex/Gender, Customized	3130 Participants n=99 Participants
Region of Enrollment Czech Republic	3130 participants n=99 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Disappearance or Significant Alleviation of Symptoms	3109 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Initial Visit - Auscultation Normal	956 participants
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Initial Visit - Auscultation Abnormal	2146 participants
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Initial Visit - Findings Not Reported	26 participants
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Second Visit - Auscultation Normal	2768 participants
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Second Visit - Auscultation Abnormal	247 participants
Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) Second Visit - Findings Not Reported	113 participants

SECONDARY outcome

Timeframe: 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.

Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Body Temperature Initial Visit - Temperature above 37 degrees C	2252 Participants
Body Temperature Initial Visit - Temperature not above 37 degrees C	870 Participants
Body Temperature Initial Visit - Temperature not reported	6 Participants
Body Temperature Second Visit - Temperature above 37 degrees C	101 Participants
Body Temperature Second Visit - Temperature not above 37 degrees C	3013 Participants
Body Temperature Second Visit - Temperature not reported	14 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=225 Participants 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.
Bacteriological Investigation (if Available) Haemophilus Influenzae	48 participants
Bacteriological Investigation (if Available) Streptococcus pneumoniae	38 participants
Bacteriological Investigation (if Available) Chlamydia pneumoniae	34 participants
Bacteriological Investigation (if Available) Mycoplasma pneumoniae	14 participants
Bacteriological Investigation (if Available) Haemophilus parainfluenzae	13 participants
Bacteriological Investigation (if Available) Klebsiella pneumoniae	12 participants
Bacteriological Investigation (if Available) Haemophilus species	10 participants
Bacteriological Investigation (if Available) Staphylococcus aureus	5 participants
Bacteriological Investigation (if Available) Branhamella catarrhalis	5 participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Cough and Its Character Initial Visit - Presence of cough	2942 Participants
Cough and Its Character a) Irritating cough	1601 Participants
Cough and Its Character b) Productive cough	1177 Participants
Cough and Its Character c) Both irritating and productive	157 Participants
Cough and Its Character d) Not Reported	7 Participants
Cough and Its Character Initial Visit -Cough not present	186 Participants
Cough and Its Character Second Visit -Presence of cough	556 Participants
Cough and Its Character a) Irritating cough.	187 Participants
Cough and Its Character b) Productive cough.	351 Participants
Cough and Its Character c) Both irritating and productive.	16 Participants
Cough and Its Character d) Not Reported.	2 Participants
Cough and Its Character Second Visit -Cough not present	2572 Participants

SECONDARY outcome

Timeframe: Day 0, Day 8-16

Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Dyspnea and Its Type Initial Visit - Presence of dyspnea	1091 Participants
Dyspnea and Its Type a) Exertional	794 Participants
Dyspnea and Its Type b) Resting	235 Participants
Dyspnea and Its Type c) Both exertional and resting	60 Participants
Dyspnea and Its Type d) Type of dyspnea not reported	2 Participants
Dyspnea and Its Type Initial Visit - Dyspnea not present	2037 Participants
Dyspnea and Its Type Second Visit - Presence of dyspnea	262 Participants
Dyspnea and Its Type a) Exertional-	234 Participants
Dyspnea and Its Type b) Resting-	17 Participants
Dyspnea and Its Type c) Both exertional and resting-	9 Participants
Dyspnea and Its Type d) Type of dyspnea not reported-	2 Participants
Dyspnea and Its Type Second Visit -Dyspnea not present	2866 Participants

SECONDARY outcome

Timeframe: 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.

Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Auscultation Initial Visit - Abnormal Auscultaton findings	2146 Participants
Auscultation a) Wheezing	1577 Participants
Auscultation b) Crackles	408 Participants
Auscultation c) Both wheezing and crackles	145 Participants
Auscultation d) Not reported	16 Participants
Auscultation Second Visit -Abnormal Auscultation findings	247 Participants
Auscultation a) Wheezing-	187 Participants
Auscultation b) Crackles-	54 Participants
Auscultation c) Both wheezing and crackles-	4 Participants
Auscultation d) Not reported-	2 Participants

SECONDARY outcome

Timeframe: Day 0

Population: Chest X-ray was performed in 294 of the participants for whom the physician suspected pneumonia.

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.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=294 Participants 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.
Chest X-ray in Case of Community-Acquired Pneumonia (CAP) Findings indicative of pneumonia	276 Participants
Chest X-ray in Case of Community-Acquired Pneumonia (CAP) Findings not indicative of pneumonia	18 Participants

SECONDARY outcome

Timeframe: Day 0

Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Study Drug Given as the First, Second or Third Antimicrobial Treatment Klacid SR as third antimicrobial treatment	2 Participants
Study Drug Given as the First, Second or Third Antimicrobial Treatment Klacid SR as first antimicrobial treatment	2910 Participants
Study Drug Given as the First, Second or Third Antimicrobial Treatment Klacid SR as second antimicrobial treatment	216 Participants

SECONDARY outcome

Timeframe: Day 8 - 16

Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Compliance	3122 Participants

SECONDARY outcome

Timeframe: Day 8 - 16

Population: A total of 3128 participants were included in the analysis.

Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.

Outcome measures

Outcome measures
Measure	Klacid SR Treatment n=3128 Participants 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.
Termination of Treatment Due to Noncompliance	6 Participants

Adverse Events

Klacid SR Treatment

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Klacid SR Treatment n=3128 participants at risk 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.
Infections and infestations Tuberculosis pleuritis	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pulmonary tumor	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.

Other adverse events

Other adverse events
Measure	Klacid SR Treatment n=3128 participants at risk 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.
Gastrointestinal disorders Bad taste in mouth	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
General disorders Loss of appetite	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Burning tongue	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Bitter taste in mouth	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Diarrhea	0.10% 3/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Dyspepsia	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Gastrointestinal tract symptoms	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Nausea	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.
Gastrointestinal disorders Vomiting	0.03% 1/3128 • Adverse events were reported from the start to the completion of treatment with Klacid SR (8 to 16 days). Serious adverse events and relapse were reported for up to 30 days after the initiation of physician prescribed study treatment. Investigator monitored study participants for adverse events as per usual practice.

Additional Information

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Phone: 1-800-633-9110

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.
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