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The aim of this post-marketing observational study (PMOS) is to describe the relief of symptoms, tolerability and compliance of treatment with Klacid®SR in a dose 1000 mg once daily in patients with lower respiratory tract infection or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP).
This PMOS will be conducted in a prospective, open-label, 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 lower respiratory tract infection, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a PMOS, 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. The decision to prescribe or not prescribe Klacid®SR would be taken prior to entry of a subject in the study.
Follow-up of patients should enable two patient visits during this period. Screening/Inclusion Visit will be performed when the decision to start the treatment with Klacid®SR is made. Inclusion of patient in the study will succeed at day 0 (S/I Visit). The Second Visit will follow 10 - 16 days after the Screening/Inclusion Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Respiratory Infections | Slovak patients with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Compliance (Was the Dosage Followed - Yes, no) | 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. | Day 10 - 16 |
| The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events | 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. | Day 0 through Days 10 - 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Temperature | 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. | Day 0 |
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Inclusion Criteria:
Men, women at least 18 years old
Exclusion Criteria:
Not provided
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Patients included in this PMOS will be those with acute tracheitis, acute tracheobronchitis, acute bronchitis, mild CAP and acute exacerbation of chronic bronchitis with infectious etiology caused probably by an atypical agent.
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| Name | Affiliation | Role |
|---|---|---|
| Adam Hloska, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 37753 | Banská Bystrica | 97401 | Slovakia | |||
| Site Reference ID/Investigator# 37758 |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Body Temperature |
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. |
| Day 10 - 16 |
| Cough and Its Character | 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. | Day 0 |
| Cough and Its Character | 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. | Day 10 - 16 |
| Dyspnoea | 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. | Day 0 |
| Dyspnoea | 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. | Day 10 - 16 |
| Auscultation | 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. | Day 0 |
| Auscultation | 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. | Day 10 - 16 |
| Banská Bystrica |
| 97401 |
| Slovakia |
| Site Reference ID/Investigator# 37806 | Bardejov | 08501 | Slovakia |
| Site Reference ID/Investigator# 38052 | Bojnice | 97201 | Slovakia |
| Site Reference ID/Investigator# 37830 | Bratislava | 81107 | Slovakia |
| Site Reference ID/Investigator# 37828 | Bratislava | 81108 | Slovakia |
| Site Reference ID/Investigator# 37823 | Bratislava | 82007 | Slovakia |
| Site Reference ID/Investigator# 37824 | Bratislava | 82007 | Slovakia |
| Site Reference ID/Investigator# 37827 | Bratislava | 82007 | Slovakia |
| Site Reference ID/Investigator# 37826 | Bratislava | 82101 | Slovakia |
| Site Reference ID/Investigator# 37680 | Bratislava | 82103 | Slovakia |
| Site Reference ID/Investigator# 37681 | Bratislava | 82106 | Slovakia |
| Site Reference ID/Investigator# 37825 | Bratislava | 82106 | Slovakia |
| Site Reference ID/Investigator# 37829 | Bratislava | 82107 | Slovakia |
| Site Reference ID/Investigator# 37732 | Bratislava | 83101 | Slovakia |
| Site Reference ID/Investigator# 37831 | Bratislava | 83299 | Slovakia |
| Site Reference ID/Investigator# 37833 | Bratislava | 83299 | Slovakia |
| Site Reference ID/Investigator# 37729 | Bratislava | 83309 | Slovakia |
| Site Reference ID/Investigator# 37840 | Bratislava | 83309 | Slovakia |
| Site Reference ID/Investigator# 37679 | Bratislava | 84101 | Slovakia |
| Site Reference ID/Investigator# 37835 | Bratislava | 84102 | Slovakia |
| Site Reference ID/Investigator# 37839 | Bratislava | 84102 | Slovakia |
| Site Reference ID/Investigator# 37834 | Bratislava | 84104 | Slovakia |
| Site Reference ID/Investigator# 37832 | Bratislava | 84108 | Slovakia |
| Site Reference ID/Investigator# 37678 | Bratislava | 84231 | Slovakia |
| Site Reference ID/Investigator# 37836 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 37837 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 37838 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 37861 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 37864 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 37866 | Bratislava | 85101 | Slovakia |
| Site Reference ID/Investigator# 25682 | Bratislava | 85104 | Slovakia |
| Site Reference ID/Investigator# 37677 | Bratislava | 85105 | Slovakia |
| Site Reference ID/Investigator# 37754 | Brezno | 97701 | Slovakia |
| Site Reference ID/Investigator# 37755 | Brezno | 97701 | Slovakia |
| Site Reference ID/Investigator# 37756 | Brezno | 97701 | Slovakia |
| Site Reference ID/Investigator# 37863 | Dojč | 90602 | Slovakia |
| Site Reference ID/Investigator# 38048 | Dolné Vestenice | 97223 | Slovakia |
| Site Reference ID/Investigator# 37694 | Dolný Kubín | 2601 | Slovakia |
| Site Reference ID/Investigator# 38029 | Drienov | 08024 | Slovakia |
| Site Reference ID/Investigator# 38056 | Dudince | 962 71 | Slovakia |
| Site Reference ID/Investigator# 37688 | Galanta | 92401 | Slovakia |
| Site Reference ID/Investigator# 37703 | Galanta | 92401 | Slovakia |
| Site Reference ID/Investigator# 37808 | Giraltovce | 08701 | Slovakia |
| Site Reference ID/Investigator# 37708 | Hôrka nad Váhom | 91632 | Slovakia |
| Site Reference ID/Investigator# 38054 | Hronské Kľačany | 95329 | Slovakia |
| Site Reference ID/Investigator# 37745 | Humenné | 06601 | Slovakia |
| Site Reference ID/Investigator# 37752 | Humenné | 06601 | Slovakia |
| Site Reference ID/Investigator# 37814 | Humenné | 06601 | Slovakia |
| Site Reference ID/Investigator# 37815 | Humenné | 06601 | Slovakia |
| Site Reference ID/Investigator# 37687 | Jelka | 92523 | Slovakia |
| Site Reference ID/Investigator# 37737 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37740 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37741 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37744 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37767 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37788 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 38030 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 38035 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 38040 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 38043 | Košice | 04001 | Slovakia |
| Site Reference ID/Investigator# 37742 | Košice | 4001 | Slovakia |
| Site Reference ID/Investigator# 37810 | Levoča | 05401 | Slovakia |
| Site Reference ID/Investigator# 37811 | Levoča | 05401 | Slovakia |
| Site Reference ID/Investigator# 37686 | Likavka | 83495 | Slovakia |
| Site Reference ID/Investigator# 37790 | Lučenec | 984 01 | Slovakia |
| Site Reference ID/Investigator# 37791 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37792 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37793 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37795 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37797 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37798 | Lučenec | 98401 | Slovakia |
| Site Reference ID/Investigator# 37690 | Ľubochňa | 3491 | Slovakia |
| Site Reference ID/Investigator# 37859 | Malacky | 90101 | Slovakia |
| Site Reference ID/Investigator# 37865 | Malacky | 90101 | Slovakia |
| Site Reference ID/Investigator# 37696 | Martin | 3601 | Slovakia |
| Site Reference ID/Investigator# 37702 | Martin | 3601 | Slovakia |
| Site Reference ID/Investigator# 37706 | Martin | 3601 | Slovakia |
| Site Reference ID/Investigator# 37743 | Michalovce | 07101 | Slovakia |
| Site Reference ID/Investigator# 37766 | Michalovce | 07101 | Slovakia |
| Site Reference ID/Investigator# 38028 | Michalovce | 07101 | Slovakia |
| Site Reference ID/Investigator# 37862 | Modra | 90001 | Slovakia |
| Site Reference ID/Investigator# 38042 | Moldava nad Bodvou | 04501 | Slovakia |
| Site Reference ID/Investigator# 37697 | Námestovo | 2901 | Slovakia |
| Site Reference ID/Investigator# 38041 | Nitra | 94901 | Slovakia |
| Site Reference ID/Investigator# 38050 | Nitra | 94901 | Slovakia |
| Site Reference ID/Investigator# 38053 | Nitra | 94911 | Slovakia |
| Site Reference ID/Investigator# 38036 | Nitra | 94988 | Slovakia |
| Site Reference ID/Investigator# 38038 | Nitra | 94988 | Slovakia |
| Site Reference ID/Investigator# 38039 | Nitra | 94988 | Slovakia |
| Site Reference ID/Investigator# 37692 | Nitrianske Pravno | 3822 | Slovakia |
| Site Reference ID/Investigator# 38047 | Nitrianske Rudno | 97226 | Slovakia |
| Site Reference ID/Investigator# 38045 | Nováky | 97271 | Slovakia |
| Site Reference ID/Investigator# 38049 | Oslany | 97247 | Slovakia |
| Site Reference ID/Investigator# 38051 | Partizánske | 95801 | Slovakia |
| Site Reference ID/Investigator# 37731 | Piešťany | 92101 | Slovakia |
| Site Reference ID/Investigator# 37858 | Piešťany | 92101 | Slovakia |
| Site Reference ID/Investigator# 37812 | Podhradie | 05304 | Slovakia |
| Site Reference ID/Investigator# 37757 | Pohorelská Maša | 97669 | Slovakia |
| Site Reference ID/Investigator# 37804 | Prešov | 08001 | Slovakia |
| Site Reference ID/Investigator# 37809 | Prešov | 08001 | Slovakia |
| Site Reference ID/Investigator# 37817 | Prešov | 08001 | Slovakia |
| Site Reference ID/Investigator# 37789 | Revúca | 05001 | Slovakia |
| Site Reference ID/Investigator# 37799 | Revúca | 05001 | Slovakia |
| Site Reference ID/Investigator# 37762 | Rimavská Sobota | 97901 | Slovakia |
| Site Reference ID/Investigator# 37763 | Rimavská Sobota | 97901 | Slovakia |
| Site Reference ID/Investigator# 37764 | Rimavská Sobota | 97901 | Slovakia |
| Site Reference ID/Investigator# 37765 | Rimavská Sobota | 97901 | Slovakia |
| Site Reference ID/Investigator# 37800 | Rožňava | 04801 | Slovakia |
| Site Reference ID/Investigator# 37801 | Rožňava | 04801 | Slovakia |
| Site Reference ID/Investigator# 37698 | Ružomberok | 034 01 | Slovakia |
| Site Reference ID/Investigator# 37693 | Ružomberok | 3401 | Slovakia |
| Site Reference ID/Investigator# 37735 | Selice | 92572 | Slovakia |
| Site Reference ID/Investigator# 37733 | Senec | 90301 | Slovakia |
| Site Reference ID/Investigator# 37730 | Senica | 90632 | Slovakia |
| Site Reference ID/Investigator# 38055 | Slatina nad Bebravou | 95653 | Slovakia |
| Site Reference ID/Investigator# 37805 | Slovinky | 05340 | Slovakia |
| Site Reference ID/Investigator# 38033 | Snina | 06901 | Slovakia |
| Site Reference ID/Investigator# 38034 | Snina | 06901 | Slovakia |
| Site Reference ID/Investigator# 38037 | Snina | 06901 | Slovakia |
| Site Reference ID/Investigator# 37746 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37747 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37748 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37750 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37751 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37813 | Spišská Nová Ves | 05201 | Slovakia |
| Site Reference ID/Investigator# 37736 | Streda nad Bodrogom | 07631 | Slovakia |
| Site Reference ID/Investigator# 38031 | Streda nad Bodrogom | 07631 | Slovakia |
| Site Reference ID/Investigator# 37860 | Stupava | 90101 | Slovakia |
| Site Reference ID/Investigator# 37816 | Svidník | 08901 | Slovakia |
| Site Reference ID/Investigator# 37685 | Šamorín | 93101 | Slovakia |
| Site Reference ID/Investigator# 38046 | Topoľčany | 95501 | Slovakia |
| Site Reference ID/Investigator# 37734 | Trenčín | 91101 | Slovakia |
| Site Reference ID/Investigator# 37699 | Trenčín | 91105 | Slovakia |
| Site Reference ID/Investigator# 37682 | Trhová Hradská | 93013 | Slovakia |
| Site Reference ID/Investigator# 37683 | Trhová Hradská | 93013 | Slovakia |
| Site Reference ID/Investigator# 37691 | Trnava | 3901 | Slovakia |
| Site Reference ID/Investigator# 37705 | Trnava | 91701 | Slovakia |
| Site Reference ID/Investigator# 37870 | Trnava | 91701 | Slovakia |
| Site Reference ID/Investigator# 37701 | Trnovec nad Váhom | 92571 | Slovakia |
| Site Reference ID/Investigator# 37695 | Turany | 3853 | Slovakia |
| Site Reference ID/Investigator# 38032 | Veľké Kapušany | 07901 | Slovakia |
| Site Reference ID/Investigator# 37868 | Veľké Kostoľany | 92207 | Slovakia |
| Site Reference ID/Investigator# 37760 | Veľký Krtíš | 99001 | Slovakia |
| Site Reference ID/Investigator# 37761 | Veľký Krtíš | 99001 | Slovakia |
| Site Reference ID/Investigator# 37807 | Vranov nad Topľou | 09301 | Slovakia |
| Site Reference ID/Investigator# 37867 | Vrbové | 92203 | Slovakia |
| Site Reference ID/Investigator# 37684 | Vrútky | 3861 | Slovakia |
| Site Reference ID/Investigator# 37869 | Zohor | 90051 | Slovakia |
| Site Reference ID/Investigator# 37794 | Zvolen | 96001 | Slovakia |
| Site Reference ID/Investigator# 37796 | Zvolen | 96001 | Slovakia |
| Site Reference ID/Investigator# 37802 | Zvolen | 96001 | Slovakia |
| Site Reference ID/Investigator# 37803 | Zvolen | 96001 | Slovakia |
| Site Reference ID/Investigator# 38044 | Žabokreky nad Nitrou | 95852 | Slovakia |
| Site Reference ID/Investigator# 37689 | Žilina | 1001 | Slovakia |
| Site Reference ID/Investigator# 37700 | Žilina | 1001 | Slovakia |
| Site Reference ID/Investigator# 37704 | Žilina | 1001 | Slovakia |
| Site Reference ID/Investigator# 37707 | Žilina | 1001 | Slovakia |
| Per Protocol Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||||||||
| Diagnosis | The diagnosis of each participant at Baseline. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Compliance (Was the Dosage Followed - Yes, no) | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 10 - 16 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 0 through Days 10 - 16 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Body Temperature | 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. | The per-protocol population was analyzed. | Posted | Number | Percentage | Day 0 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Body Temperature | 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. | The per-protocol population was analyzed. | Posted | Number | Percentage | Day 10 - 16 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Cough and Its Character | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 0 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Cough and Its Character | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 10 - 16 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dyspnoea | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 0 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Dyspnoea | 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. | Posted | Number | Participants | Day 10 - 16 |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Auscultation | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 0 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Auscultation | 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. | The per-protocol population was analyzed. | Posted | Number | Participants | Day 10 - 16 |
|
|
Adverse events were collected through Visit 2 (10 to 16 days).
Adverse events are based on the per-protocol population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3,181 | 7 | 3,181 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea, abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Vomiting, transient exanthema | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
| |
| Headache, nausea, bad taste in mouth | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 1-800-633-9110 |
| ID | Term |
|---|---|
| D014136 | Tracheitis |
| D001991 | Bronchitis |
| D029481 | Bronchitis, Chronic |
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D014133 | Tracheal Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017714 | Community-Acquired Infections |
| D011014 | Pneumonia |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 40 to 49 years |
|
| 50 to 59 years |
|
| 60 to 69 years |
|
| 70 to 79 years |
|
| 80 years or older |
|
| Age not reported |
|
| Acute tracheitis |
|
| Acute exacerbation of chronic bronchitis |
|
| Mild community-acquired bronchopneumonia |
|
| Title | Measurements |
|---|---|
|
| >Participant felt better |
|
| >Diarrhea |
|
| >Reason not reported |
|
|
|
|
|
|
|
|
|
|