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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01108185
• Collaborator: (none)
• Enrollment: 3,181
• Locations: 158
• Duration (Months): 4
• Patients Per Site: 20.1
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Tracheitis; Tracheobronchitis; Bronchitis; Chronic Bronchitis; Community-acquired Pneumonia

Detailed Description

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 3181 participants
• Time Perspective: Prospective
• Official Title: Evaluation of the Treatment With Klacid SR in Patients With Acute Tracheitis, Tracheobronchitis and Bronchitis, Acute Exacerbation of Chronic Bronchitis or Mild Community-acquired Bronchopneumonia in Common Clinical Practice in the Slovak Republic
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. Compliance (Was the Dosage Followed - Yes, no) [Day 10 - 16]

   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.

2. The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events [Day 0 through Days 10 - 16]

   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.

Secondary Outcome Measures

1. Body Temperature [Day 0]

   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.

2. Body Temperature [Day 10 - 16]

   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.

3. Cough and Its Character [Day 0]

   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.

4. Cough and Its Character [Day 10 - 16]

   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.

5. Dyspnoea [Day 0]

   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.

6. Dyspnoea [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.

7. Auscultation [Day 0]

   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.

8. Auscultation [Day 10 - 16]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men, women at least 18 years old

• with acute tracheitis,

• acute tracheobronchitis,

• acute bronchitis,

• mild community-acquired pneumonia or

• acute exacerbation of chronic bronchitis

Exclusion Criteria:

• Patients with known hypersensitivity to macrolide antibiotics

• Patients with documented renal impairment (creatinine clearance under 30 ml/min).

• Patients with documented liver parenchyma impairment (AST, ALT and GMT > 3x higher level in comparison with the norm)

• Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine

• Pregnancy

• Breast feeding

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 37753	Banska Bystrica		Slovakia	97401
2	Site Reference ID/Investigator# 37758	Banska Bystrica		Slovakia	97401
3	Site Reference ID/Investigator# 37806	Bardejov		Slovakia	08501
4	Site Reference ID/Investigator# 38052	Bojnice		Slovakia	97201
5	Site Reference ID/Investigator# 37830	Bratislava		Slovakia	81107
6	Site Reference ID/Investigator# 37828	Bratislava		Slovakia	81108
7	Site Reference ID/Investigator# 37823	Bratislava		Slovakia	82007
8	Site Reference ID/Investigator# 37824	Bratislava		Slovakia	82007
9	Site Reference ID/Investigator# 37827	Bratislava		Slovakia	82007
10	Site Reference ID/Investigator# 37826	Bratislava		Slovakia	82101
11	Site Reference ID/Investigator# 37680	Bratislava		Slovakia	82103
12	Site Reference ID/Investigator# 37681	Bratislava		Slovakia	82106
13	Site Reference ID/Investigator# 37825	Bratislava		Slovakia	82106
14	Site Reference ID/Investigator# 37829	Bratislava		Slovakia	82107
15	Site Reference ID/Investigator# 37732	Bratislava		Slovakia	83101
16	Site Reference ID/Investigator# 37831	Bratislava		Slovakia	83299
17	Site Reference ID/Investigator# 37833	Bratislava		Slovakia	83299
18	Site Reference ID/Investigator# 37729	Bratislava		Slovakia	83309
19	Site Reference ID/Investigator# 37840	Bratislava		Slovakia	83309
20	Site Reference ID/Investigator# 37679	Bratislava		Slovakia	84101
21	Site Reference ID/Investigator# 37835	Bratislava		Slovakia	84102
22	Site Reference ID/Investigator# 37839	Bratislava		Slovakia	84102
23	Site Reference ID/Investigator# 37834	Bratislava		Slovakia	84104
24	Site Reference ID/Investigator# 37832	Bratislava		Slovakia	84108
25	Site Reference ID/Investigator# 37678	Bratislava		Slovakia	84231
26	Site Reference ID/Investigator# 37836	Bratislava		Slovakia	85101
27	Site Reference ID/Investigator# 37837	Bratislava		Slovakia	85101
28	Site Reference ID/Investigator# 37838	Bratislava		Slovakia	85101
29	Site Reference ID/Investigator# 37861	Bratislava		Slovakia	85101
30	Site Reference ID/Investigator# 37864	Bratislava		Slovakia	85101
31	Site Reference ID/Investigator# 37866	Bratislava		Slovakia	85101
32	Site Reference ID/Investigator# 25682	Bratislava		Slovakia	85104
33	Site Reference ID/Investigator# 37677	Bratislava		Slovakia	85105
34	Site Reference ID/Investigator# 37754	Brezno		Slovakia	97701
35	Site Reference ID/Investigator# 37755	Brezno		Slovakia	97701
36	Site Reference ID/Investigator# 37756	Brezno		Slovakia	97701
37	Site Reference ID/Investigator# 37863	Dojc		Slovakia	90602
38	Site Reference ID/Investigator# 38048	Dolne Vestenice		Slovakia	97223
39	Site Reference ID/Investigator# 37694	Dolny Kubin		Slovakia	2601
40	Site Reference ID/Investigator# 38029	Drienov		Slovakia	08024
41	Site Reference ID/Investigator# 38056	Dudince		Slovakia	962 71
42	Site Reference ID/Investigator# 37688	Galanta		Slovakia	92401
43	Site Reference ID/Investigator# 37703	Galanta		Slovakia	92401
44	Site Reference ID/Investigator# 37808	Giraltovce		Slovakia	08701
45	Site Reference ID/Investigator# 37708	Horka nad Vahom		Slovakia	91632
46	Site Reference ID/Investigator# 38054	Hronske Klacany		Slovakia	95329
47	Site Reference ID/Investigator# 37745	Humenne		Slovakia	06601
48	Site Reference ID/Investigator# 37752	Humenne		Slovakia	06601
49	Site Reference ID/Investigator# 37814	Humenne		Slovakia	06601
50	Site Reference ID/Investigator# 37815	Humenne		Slovakia	06601
51	Site Reference ID/Investigator# 37687	Jelka		Slovakia	92523
52	Site Reference ID/Investigator# 37737	Kosice		Slovakia	04001
53	Site Reference ID/Investigator# 37740	Kosice		Slovakia	04001
54	Site Reference ID/Investigator# 37741	Kosice		Slovakia	04001
55	Site Reference ID/Investigator# 37744	Kosice		Slovakia	04001
56	Site Reference ID/Investigator# 37767	Kosice		Slovakia	04001
57	Site Reference ID/Investigator# 37788	Kosice		Slovakia	04001
58	Site Reference ID/Investigator# 38030	Kosice		Slovakia	04001
59	Site Reference ID/Investigator# 38035	Kosice		Slovakia	04001
60	Site Reference ID/Investigator# 38040	Kosice		Slovakia	04001
61	Site Reference ID/Investigator# 38043	Kosice		Slovakia	04001
62	Site Reference ID/Investigator# 37742	Kosice		Slovakia	4001
63	Site Reference ID/Investigator# 37810	Levoca		Slovakia	05401
64	Site Reference ID/Investigator# 37811	Levoca		Slovakia	05401
65	Site Reference ID/Investigator# 37686	Likavka		Slovakia	83495
66	Site Reference ID/Investigator# 37690	Lubochna		Slovakia	3491
67	Site Reference ID/Investigator# 37790	Lucenec		Slovakia	984 01
68	Site Reference ID/Investigator# 37791	Lucenec		Slovakia	98401
69	Site Reference ID/Investigator# 37792	Lucenec		Slovakia	98401
70	Site Reference ID/Investigator# 37793	Lucenec		Slovakia	98401
71	Site Reference ID/Investigator# 37795	Lucenec		Slovakia	98401
72	Site Reference ID/Investigator# 37797	Lucenec		Slovakia	98401
73	Site Reference ID/Investigator# 37798	Lucenec		Slovakia	98401
74	Site Reference ID/Investigator# 37859	Malacky		Slovakia	90101
75	Site Reference ID/Investigator# 37865	Malacky		Slovakia	90101
76	Site Reference ID/Investigator# 37696	Martin		Slovakia	3601
77	Site Reference ID/Investigator# 37702	Martin		Slovakia	3601
78	Site Reference ID/Investigator# 37706	Martin		Slovakia	3601
79	Site Reference ID/Investigator# 37743	Michalovce		Slovakia	07101
80	Site Reference ID/Investigator# 37766	Michalovce		Slovakia	07101
81	Site Reference ID/Investigator# 38028	Michalovce		Slovakia	07101
82	Site Reference ID/Investigator# 37862	Modra		Slovakia	90001
83	Site Reference ID/Investigator# 38042	Moldava nad Bodvou		Slovakia	04501
84	Site Reference ID/Investigator# 37697	Namestovo		Slovakia	2901
85	Site Reference ID/Investigator# 38041	Nitra		Slovakia	94901
86	Site Reference ID/Investigator# 38050	Nitra		Slovakia	94901
87	Site Reference ID/Investigator# 38053	Nitra		Slovakia	94911
88	Site Reference ID/Investigator# 38036	Nitra		Slovakia	94988
89	Site Reference ID/Investigator# 38038	Nitra		Slovakia	94988
90	Site Reference ID/Investigator# 38039	Nitra		Slovakia	94988
91	Site Reference ID/Investigator# 37692	Nitrianske Pravno		Slovakia	3822
92	Site Reference ID/Investigator# 38047	Nitrianske Rudno		Slovakia	97226
93	Site Reference ID/Investigator# 38045	Novaky		Slovakia	97271
94	Site Reference ID/Investigator# 38049	Oslany		Slovakia	97247
95	Site Reference ID/Investigator# 38051	Partizanske		Slovakia	95801
96	Site Reference ID/Investigator# 37731	Piestany		Slovakia	92101
97	Site Reference ID/Investigator# 37858	Piestany		Slovakia	92101
98	Site Reference ID/Investigator# 37812	Podhradie		Slovakia	05304
99	Site Reference ID/Investigator# 37757	Pohorelska Masa		Slovakia	97669
100	Site Reference ID/Investigator# 37804	Presov		Slovakia	08001
101	Site Reference ID/Investigator# 37809	Presov		Slovakia	08001
102	Site Reference ID/Investigator# 37817	Presov		Slovakia	08001
103	Site Reference ID/Investigator# 37789	Revuca		Slovakia	05001
104	Site Reference ID/Investigator# 37799	Revuca		Slovakia	05001
105	Site Reference ID/Investigator# 37762	Rimavska Sobota		Slovakia	97901
106	Site Reference ID/Investigator# 37763	Rimavska Sobota		Slovakia	97901
107	Site Reference ID/Investigator# 37764	Rimavska Sobota		Slovakia	97901
108	Site Reference ID/Investigator# 37765	Rimavska Sobota		Slovakia	97901
109	Site Reference ID/Investigator# 37800	Roznava		Slovakia	04801
110	Site Reference ID/Investigator# 37801	Roznava		Slovakia	04801
111	Site Reference ID/Investigator# 37698	Ruzomberok		Slovakia	034 01
112	Site Reference ID/Investigator# 37693	Ruzomberok		Slovakia	3401
113	Site Reference ID/Investigator# 37685	Samorin		Slovakia	93101
114	Site Reference ID/Investigator# 37735	Selice		Slovakia	92572
115	Site Reference ID/Investigator# 37733	Senec		Slovakia	90301
116	Site Reference ID/Investigator# 37730	Senica		Slovakia	90632
117	Site Reference ID/Investigator# 38055	Slatina nad Bebravou		Slovakia	95653
118	Site Reference ID/Investigator# 37805	Slovinky		Slovakia	05340
119	Site Reference ID/Investigator# 38033	Snina		Slovakia	06901
120	Site Reference ID/Investigator# 38034	Snina		Slovakia	06901
121	Site Reference ID/Investigator# 38037	Snina		Slovakia	06901
122	Site Reference ID/Investigator# 37746	Spisska Nova Ves		Slovakia	05201
123	Site Reference ID/Investigator# 37747	Spisska Nova Ves		Slovakia	05201
124	Site Reference ID/Investigator# 37748	Spisska Nova Ves		Slovakia	05201
125	Site Reference ID/Investigator# 37750	Spisska Nova Ves		Slovakia	05201
126	Site Reference ID/Investigator# 37751	Spisska Nova Ves		Slovakia	05201
127	Site Reference ID/Investigator# 37813	Spisska Nova Ves		Slovakia	05201
128	Site Reference ID/Investigator# 37736	Streda nad Bodrogom		Slovakia	07631
129	Site Reference ID/Investigator# 38031	Streda nad Bodrogom		Slovakia	07631
130	Site Reference ID/Investigator# 37860	Stupava		Slovakia	90101
131	Site Reference ID/Investigator# 37816	Svidnik		Slovakia	08901
132	Site Reference ID/Investigator# 38046	Topolcany		Slovakia	95501
133	Site Reference ID/Investigator# 37734	Trencin		Slovakia	91101
134	Site Reference ID/Investigator# 37699	Trencin		Slovakia	91105
135	Site Reference ID/Investigator# 37682	Trhova Hradska		Slovakia	93013
136	Site Reference ID/Investigator# 37683	Trhova Hradska		Slovakia	93013
137	Site Reference ID/Investigator# 37691	Trnava		Slovakia	3901
138	Site Reference ID/Investigator# 37705	Trnava		Slovakia	91701
139	Site Reference ID/Investigator# 37870	Trnava		Slovakia	91701
140	Site Reference ID/Investigator# 37701	Trnovec nad Vahom		Slovakia	92571
141	Site Reference ID/Investigator# 37695	Turany		Slovakia	3853
142	Site Reference ID/Investigator# 38032	Velke Kapusany		Slovakia	07901
143	Site Reference ID/Investigator# 37868	Velke Kostolany		Slovakia	92207
144	Site Reference ID/Investigator# 37760	Velky Krtis		Slovakia	99001
145	Site Reference ID/Investigator# 37761	Velky Krtis		Slovakia	99001
146	Site Reference ID/Investigator# 37807	Vranov nad Topľou		Slovakia	09301
147	Site Reference ID/Investigator# 37867	Vrbove		Slovakia	92203
148	Site Reference ID/Investigator# 37684	Vrutky		Slovakia	3861
149	Site Reference ID/Investigator# 38044	Zabokreky nad Nitrou		Slovakia	95852
150	Site Reference ID/Investigator# 37689	Zilina		Slovakia	1001
151	Site Reference ID/Investigator# 37700	Zilina		Slovakia	1001
152	Site Reference ID/Investigator# 37704	Zilina		Slovakia	1001
153	Site Reference ID/Investigator# 37707	Zilina		Slovakia	1001
154	Site Reference ID/Investigator# 37869	Zohor		Slovakia	90051
155	Site Reference ID/Investigator# 37794	Zvolen		Slovakia	96001
156	Site Reference ID/Investigator# 37796	Zvolen		Slovakia	96001
157	Site Reference ID/Investigator# 37802	Zvolen		Slovakia	96001
158	Site Reference ID/Investigator# 37803	Zvolen		Slovakia	96001

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Adam Hloska, M.D., Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01108185
• Other Study ID Numbers: P12-060
• First Posted: Apr 21, 2010
• Last Update Posted: Sep 13, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Abbott: treatment with Klacid®SR; tracheitis; tracheobronchitis; bronchitis; chronic bronchitis; community-acquired pneumonia
• Additional relevant MeSH terms: Pneumonia; Bronchitis; Bronchitis, Chronic; Tracheitis; Acute Disease

Study Results

Participant Flow

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Period Title: Overall Study
STARTED	3181
Per Protocol Population	3181
COMPLETED	3154
NOT COMPLETED	27

Baseline Characteristics

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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 Participants	3181
Age, Customized (participants) [Number]
Less than 20 years	50 1.6%
20 to 29 years	411 12.9%
30 to 39 years	873 27.4%
40 to 49 years	787 24.7%
50 to 59 years	538 16.9%
60 to 69 years	331 10.4%
70 to 79 years	130 4.1%
80 years or older	50 1.6%
Age not reported	11 0.3%
Sex: Female, Male (Count of Participants)
Female	NA NaN
Male	NA NaN
Region of Enrollment (participants) [Number]
Slovakia	3181 100%
Diagnosis (Number) [Number]
Acute tracheobronchitis	926 29.1%
Acute bronchitis	921 29%
Acute tracheitis	870 27.3%
Acute exacerbation of chronic bronchitis	281 8.8%
Mild community-acquired bronchopneumonia	183 5.8%

Outcome Measures

1. Primary Outcome

Title	Compliance (Was the Dosage Followed - Yes, no)
Description	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.
Time Frame	Day 10 - 16

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Completed course of therapy	3154 99.2%
Did not complete (lost to follow-up)	12 0.4%
Did not complete (noncompliance)	15 0.5%
>Participant felt better	2 0.1%
>Diarrhea	1 0%
>Reason not reported	12 0.4%

2. Primary Outcome

Title	The Tolerability of Klacid SR Will be Assessed by Evaluation of Adverse Events
Description	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.
Time Frame	Day 0 through Days 10 - 16

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Non-serious adverse events (AEs)	7 0.2%
Serious AEs	0 0%
Discontinued due to AEs	0 0%

3. Secondary Outcome

Title	Body Temperature
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Body temperature greater than 37 ºC at Day 0	84
Body temperature less than 37 ºC at Day 0	15
Body temperature not reported at Day 0	1

4. Secondary Outcome

Title	Body Temperature
Description	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.
Time Frame	Day 10 - 16

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Body temperature greater than 37 ºC at Visit 2	1
Body temperature less than 37 ºC at Visit 2	98
Body temperature not reported at Visit 2	1

5. Secondary Outcome

Title	Cough and Its Character
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Had irritating cough	1920 60.4%
Had productive cough	1152 36.2%
Did not have cough	101 3.2%
Presence or absence of cough not reported	8 0.3%

6. Secondary Outcome

Title	Cough and Its Character
Description	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.
Time Frame	Day 10 - 16

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Had irritating cough	164 5.2%
Had productive cough	178 5.6%
Did not have cough	2828 88.9%
Presence or absence of cough not reported	11 0.3%

7. Secondary Outcome

Title	Dyspnoea
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Had resting dyspnoea	141 4.4%
Had exertional dyspnoea	634 19.9%
Did not have dyspnoea	2398 75.4%
Presence or absence of dyspnoea not reported	8 0.3%

8. Secondary Outcome

Title	Dyspnoea
Description	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.
Time Frame	Day 10 - 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Had resting dyspnoea	12 0.4%
Had exertional dyspnoea	27 0.8%
Did not have dyspnoea	3128 98.3%
Presence or absence of dyspnoea not reported	14 0.4%

9. Secondary Outcome

Title	Auscultation
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Normal breath sounds	917 28.8%
Wheezing	1223 38.4%
Crackles	1030 32.4%
Breath sounds not reported	11 0.3%

10. Secondary Outcome

Title	Auscultation
Description	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.
Time Frame	Day 10 - 16

Outcome Measure Data

Analysis Population Description

The per-protocol population was analyzed.

Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
Measure Participants	3181
Normal breath sounds	3115 97.9%
Wheezing	36 1.1%
Crackles	15 0.5%
Breath sounds not reported	15 0.5%

Adverse Events

Time Frame	Adverse events were collected through Visit 2 (10 to 16 days).
Adverse Event Reporting Description	Adverse events are based on the per-protocol population.
Arm/Group Title	Acute Respiratory Infections
Arm/Group Description	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.
All Cause Mortality
	Acute Respiratory Infections
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Acute Respiratory Infections
	Affected / at Risk (%)	# Events
Total	0/3181 (0%)
Other (Not Including Serious) Adverse Events
	Acute Respiratory Infections
	Affected / at Risk (%)	# Events
Total	7/3181 (0.2%)
Gastrointestinal disorders
Diarrhea, abdominal pain	1/3181 (0%)	1
Diarrhea	1/3181 (0%)	1
Nausea	1/3181 (0%)	1
Dyspepsia	1/3181 (0%)	1
Vomiting	1/3181 (0%)	1
Vomiting, transient exanthema	1/3181 (0%)	1
Nervous system disorders
Headache, nausea, bad taste in mouth	1/3181 (0%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.