Trial Outcomes & Findings for Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection (NCT NCT01108185)

NCT ID: NCT01108185

Last Updated: 2011-09-13

Results Overview

Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.

• Recruitment status: COMPLETED
• Target enrollment: 3181 participants
• Primary outcome timeframe: Day 10 - 16
• Results posted on: 2011-09-13

Participant Flow

Participant milestones

Measure	Acute Respiratory Infections Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Overall Study STARTED	3181
Overall Study Per Protocol Population	3181
Overall Study COMPLETED	3154
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Measure	Acute Respiratory Infections Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Overall Study Non-compliance	15
Overall Study Lost to Follow-up	12

Baseline Characteristics

Evaluation of the Treatment With Klacid®SR in Patients With Lower Respiratory Tract Infection

Baseline characteristics by cohort

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Age, Customized Less than 20 years	50 participants n=5 Participants
Age, Customized 20 to 29 years	411 participants n=5 Participants
Age, Customized 30 to 39 years	873 participants n=5 Participants
Age, Customized 40 to 49 years	787 participants n=5 Participants
Age, Customized 50 to 59 years	538 participants n=5 Participants
Age, Customized 60 to 69 years	331 participants n=5 Participants
Age, Customized 70 to 79 years	130 participants n=5 Participants
Age, Customized 80 years or older	50 participants n=5 Participants
Age, Customized Age not reported	11 participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment Slovakia	3181 participants n=5 Participants
Diagnosis Acute tracheobronchitis	926 Participants n=5 Participants
Diagnosis Acute bronchitis	921 Participants n=5 Participants
Diagnosis Acute tracheitis	870 Participants n=5 Participants
Diagnosis Acute exacerbation of chronic bronchitis	281 Participants n=5 Participants
Diagnosis Mild community-acquired bronchopneumonia	183 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 10 - 16

Population: The per-protocol population was analyzed.

Compliance was assessed by asking physicians if participants took their medication as directed and if not, the reason for noncompliance. The number of participants that completed their course of therapy or did not complete due to noncompliance is reported.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Compliance (Was the Dosage Followed - Yes, no) >Participant felt better	2 Participants
Compliance (Was the Dosage Followed - Yes, no) Completed course of therapy	3154 Participants
Compliance (Was the Dosage Followed - Yes, no) Did not complete (lost to follow-up)	12 Participants
Compliance (Was the Dosage Followed - Yes, no) Did not complete (noncompliance)	15 Participants
Compliance (Was the Dosage Followed - Yes, no) >Diarrhea	1 Participants
Compliance (Was the Dosage Followed - Yes, no) >Reason not reported	12 Participants

PRIMARY outcome

Timeframe: Day 0 through Days 10 - 16

Population: The per-protocol population was analyzed.

The number of participants experiencing adverse events, serious adverse events, or adverse events leading to study discontinuation are summarized. See Reported Adverse Events for additional details.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events Non-serious adverse events (AEs)	7 Participants
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events Serious AEs	0 Participants
The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events Discontinued due to AEs	0 Participants

SECONDARY outcome

Timeframe: Day 0

Population: The per-protocol population was analyzed.

Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Day 0 (Baseline) is summarized.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Body Temperature Body temperature greater than 37 ºC at Day 0	84 Percentage
Body Temperature Body temperature less than 37 ºC at Day 0	15 Percentage
Body Temperature Body temperature not reported at Day 0	1 Percentage

SECONDARY outcome

Timeframe: Day 10 - 16

Population: The per-protocol population was analyzed.

Body temperature was measured at Day 0 (Baseline) and 10 to 16 days later (Visit 2). Increased body temperature was defined as body temperature greater than or equal to 37 degrees Celsius/98.6 Fahrenheit. The percentage of participants with increased or normal body temperature at Visit 2 is summarized.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Body Temperature Body temperature greater than 37 ºC at Visit 2	1 Percentage
Body Temperature Body temperature less than 37 ºC at Visit 2	98 Percentage
Body Temperature Body temperature not reported at Visit 2	1 Percentage

SECONDARY outcome

Timeframe: Day 0

Population: The per-protocol population was analyzed.

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Baseline is presented.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Cough and Its Character Had irritating cough	1920 Participants
Cough and Its Character Had productive cough	1152 Participants
Cough and Its Character Did not have cough	101 Participants
Cough and Its Character Presence or absence of cough not reported	8 Participants

SECONDARY outcome

Timeframe: Day 10 - 16

Population: The per-protocol population was analyzed.

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The presence of cough and the type of cough (productive or irritating) was determined by the treating physician based on clinical judgment. The number of participants with each type of cough or no cough at Visit 2 is presented.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Cough and Its Character Did not have cough	2828 Participants
Cough and Its Character Presence or absence of cough not reported	11 Participants
Cough and Its Character Had irritating cough	164 Participants
Cough and Its Character Had productive cough	178 Participants

SECONDARY outcome

Timeframe: Day 0

Population: The per-protocol population was analyzed.

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Baseline is presented.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Dyspnoea Had resting dyspnoea	141 Participants
Dyspnoea Had exertional dyspnoea	634 Participants
Dyspnoea Did not have dyspnoea	2398 Participants
Dyspnoea Presence or absence of dyspnoea not reported	8 Participants

SECONDARY outcome

Timeframe: Day 10 - 16

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physicians used their clinical judgment to determine the presence of dyspnoea (difficulty breathing) and whether it occurred while resting or after exertion. The number of participants with each type of dyspnoea or with no dyspnoea at Visit 2 is presented.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Dyspnoea Had resting dyspnoea	12 Participants
Dyspnoea Had exertional dyspnoea	27 Participants
Dyspnoea Did not have dyspnoea	3128 Participants
Dyspnoea Presence or absence of dyspnoea not reported	14 Participants

SECONDARY outcome

Timeframe: Day 0

Population: The per-protocol population was analyzed.

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Baseline is summarized.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Auscultation Normal breath sounds	917 Participants
Auscultation Wheezing	1223 Participants
Auscultation Crackles	1030 Participants
Auscultation Breath sounds not reported	11 Participants

SECONDARY outcome

Timeframe: Day 10 - 16

Population: The per-protocol population was analyzed.

Participants were evaluated at Day 0 (Baseline) and 10 to 16 days later (Visit 2). The treating physician used their clinical judgment to determine the presence of abnormal breathing sounds such as wheezing or crackles using auscultation (listening for sounds within the body, usually with a stethoscope in the chest, neck or abdomen). The number of participants with each type of breath sound at Visit 2 is summarized.

Outcome measures

Measure	Acute Respiratory Infections n=3181 Participants Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Auscultation Normal breath sounds	3115 Participants
Auscultation Wheezing	36 Participants
Auscultation Crackles	15 Participants
Auscultation Breath sounds not reported	15 Participants

Adverse Events

Acute Respiratory Infections

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Acute Respiratory Infections n=3181 participants at risk Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
Gastrointestinal disorders Diarrhea, abdominal pain	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Gastrointestinal disorders Diarrhea	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Gastrointestinal disorders Nausea	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Gastrointestinal disorders Dyspepsia	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Gastrointestinal disorders Vomiting	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Gastrointestinal disorders Vomiting, transient exanthema	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.
Nervous system disorders Headache, nausea, bad taste in mouth	0.03% 1/3181 • Number of events 1 • Adverse events were collected through Visit 2 (10 to 16 days). Adverse events are based on the per-protocol population.

Additional Information

Global Medical Services

Abbott

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.
• Publication restrictions are in place

Restriction type: OTHER