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

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01130883
• Collaborator: (none)
• Enrollment: 3,130
• Locations: 135
• Duration (Months): 4.9
• Patients Per Site: 23.2
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, 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 acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, 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. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients 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 administered within this study.

Condition or Disease	Intervention/Treatment	Phase
Tracheitis; Tracheobronchitis; Bronchitis; Chronic Bronchitis; Community-Acquired Pneumonia (CAP)

Detailed Description

Follow-up of participants should enable three visits during this period. At the Screening Visit the decision for Klacid SR therapy in a dose of 500 -1000 mg once daily will be made. The Second Visit will occur 8 - 16 days after study initiation. The Last Visit will be a phone call to the participant after 30 days from the initiation of the treatment. Study visits will be defined as "V1" = Screening Visit, "V2" = Visit in which Klacid SR therapy will be terminated and "V3" = Phone call 30 days after initiation of Klacid SR therapy.

Study Design

• Study Type: Observational
• Actual Enrollment: 3130 participants
• Time Perspective: Prospective
• Official Title: Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR in Patients With Upper Respiratory Infection, Exacerbation of Chronic Bronchitis and Mild Community-acquired Pneumonia in Common Clinical Practice in the Czech Republic
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Respiratory Infections Czech patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid®SR treatment 6 weeks prior to the next Klacid®SR dose or in intervals: 7-week - 3- month, 4- month - 12- month, 13- month - 24- month prior to the next Klacid®SR dose (next Klacid®SR dose = dose administered within this PMOS).

Outcome Measures

Primary Outcome Measures

1. Disappearance or Significant Alleviation of Symptoms [Day 8 - 16]

   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.

2. Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) [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).

Secondary Outcome Measures

1. Body Temperature [Day 0, Day 8-16]

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

2. Bacteriological Investigation (if Available) [Day 0]

   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.

3. Cough and Its Character [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)

4. Dyspnea and Its Type [Day 0, Day 8-16]

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

5. Auscultation [Day 0, Day 8-16]

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

6. Chest X-ray in Case of Community-Acquired Pneumonia (CAP) [Day 0]

   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.

7. Study Drug Given as the First, Second or Third Antimicrobial Treatment [Day 0]

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

8. Compliance [Day 8 - 16]

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

9. Termination of Treatment Due to Noncompliance [Day 8 - 16]

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

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.

• Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.

• Patients:

• with acute tracheitis,

• acute tracheobronchitis,

• acute bronchitis,

• mild community-acquired pneumonia or

• acute exacerbation of chronic bronchitis

Exclusion Criteria:

• Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.

• 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# 37381	Bilina		Czech Republic	418 01
2	Site Reference ID/Investigator# 37391	Bilina		Czech Republic	418 01
3	Site Reference ID/Investigator# 37282	Blansko		Czech Republic	678 01
4	Site Reference ID/Investigator# 37324	Blansko		Czech Republic	678 01
5	Site Reference ID/Investigator# 37424	Boskovice		Czech Republic	680 01
6	Site Reference ID/Investigator# 37329	Brandys nad Labem		Czech Republic	250 01
7	Site Reference ID/Investigator# 37443	Breclav		Czech Republic	690 02
8	Site Reference ID/Investigator# 37268	Brno		Czech Republic	602 00
9	Site Reference ID/Investigator# 37299	Brno		Czech Republic	602 00
10	Site Reference ID/Investigator# 37331	Brno		Czech Republic	602 00
11	Site Reference ID/Investigator# 37396	Brno		Czech Republic	602 00
12	Site Reference ID/Investigator# 37411	Brno		Czech Republic	602 00
13	Site Reference ID/Investigator# 37403	Brno		Czech Republic	60200
14	Site Reference ID/Investigator# 37380	Brno		Czech Republic	616 00
15	Site Reference ID/Investigator# 37327	Brno		Czech Republic	636 00
16	Site Reference ID/Investigator# 37429	Bucovice		Czech Republic	685 01
17	Site Reference ID/Investigator# 37444	Bucovice		Czech Republic	685 01
18	Site Reference ID/Investigator# 37298	Budweis		Czech Republic	370 01
19	Site Reference ID/Investigator# 37433	Bustehrad		Czech Republic	273 43
20	Site Reference ID/Investigator# 37374	Caslav		Czech Republic	286 01
21	Site Reference ID/Investigator# 37267	Ceske Budejovice		Czech Republic	370 01
22	Site Reference ID/Investigator# 37269	Ceske Budejovice		Czech Republic	370 01
23	Site Reference ID/Investigator# 37302	Ceske Budejovice		Czech Republic	370 01
24	Site Reference ID/Investigator# 37392	Ceske Budejovice		Czech Republic	370 05
25	Site Reference ID/Investigator# 37408	Ceske Budejovice		Czech Republic	370 87
26	Site Reference ID/Investigator# 37362	Cheb		Czech Republic	350 03
27	Site Reference ID/Investigator# 47286	Cheb		Czech Republic	35002
28	Site Reference ID/Investigator# 37413	Chrudim		Czech Republic	537 01
29	Site Reference ID/Investigator# 37372	Decin		Czech Republic	405 01
30	Site Reference ID/Investigator# 37394	Decin		Czech Republic	40501
31	Site Reference ID/Investigator# 26623	Hardec Kralove		Czech Republic	500 02
32	Site Reference ID/Investigator# 37270	Hardec Kralove		Czech Republic	500 02
33	Site Reference ID/Investigator# 37371	Hardec Kralove		Czech Republic	500 02
34	Site Reference ID/Investigator# 43225	Hardec Kralove		Czech Republic	500 02
35	Site Reference ID/Investigator# 37263	Holesov		Czech Republic	769 01
36	Site Reference ID/Investigator# 43230	Holesov		Czech Republic	769 01
37	Site Reference ID/Investigator# 37274	Hradek		Czech Republic	338 42
38	Site Reference ID/Investigator# 37367	Hranice		Czech Republic	753 01
39	Site Reference ID/Investigator# 37364	Hrebec		Czech Republic	273 45
40	Site Reference ID/Investigator# 37404	Jablonec nad Nisou		Czech Republic	466 04
41	Site Reference ID/Investigator# 47283	Jablonec nad Nisou		Czech Republic	468 01
42	Site Reference ID/Investigator# 43229	Jaromer		Czech Republic	551 02
43	Site Reference ID/Investigator# 37376	Jindrichuv Hradec		Czech Republic	377 01
44	Site Reference ID/Investigator# 37290	Kaplice		Czech Republic	382 41
45	Site Reference ID/Investigator# 37369	Karlovy Vary		Czech Republic	360 01
46	Site Reference ID/Investigator# 37445	Karlovy Vary		Czech Republic	360 01
47	Site Reference ID/Investigator# 37363	Karlovy Vary		Czech Republic	360 17
48	Site Reference ID/Investigator# 37283	Kladno		Czech Republic	272 01
49	Site Reference ID/Investigator# 37382	Kolin		Czech Republic	280 02
50	Site Reference ID/Investigator# 37368	Konice		Czech Republic	798 52
51	Site Reference ID/Investigator# 37415	Konice		Czech Republic	798 52
52	Site Reference ID/Investigator# 37272	Kralovice		Czech Republic	331 41
53	Site Reference ID/Investigator# 42162	Kunovice		Czech Republic	68604
54	Site Reference ID/Investigator# 43224	Kyjov		Czech Republic	697 01
55	Site Reference ID/Investigator# 37323	Letohrad		Czech Republic	561 51
56	Site Reference ID/Investigator# 37389	Liberec		Czech Republic	460 01
57	Site Reference ID/Investigator# 37416	Litomysl		Czech Republic	570 01
58	Site Reference ID/Investigator# 37384	Litvinov		Czech Republic	43542
59	Site Reference ID/Investigator# 37428	Marianske Lazne		Czech Republic	353 01
60	Site Reference ID/Investigator# 37289	Melnik		Czech Republic	276 01
61	Site Reference ID/Investigator# 37293	Mestec Kralove		Czech Republic	289 03
62	Site Reference ID/Investigator# 43228	Mohelnice		Czech Republic	78985
63	Site Reference ID/Investigator# 43233	Mohelnice		Czech Republic	78985
64	Site Reference ID/Investigator# 43227	Moravska Trebova		Czech Republic	571 01
65	Site Reference ID/Investigator# 47290	Most		Czech Republic
66	Site Reference ID/Investigator# 37297	Neratovice		Czech Republic	277 11
67	Site Reference ID/Investigator# 37397	Novy Bor		Czech Republic	473 01
68	Site Reference ID/Investigator# 37303	Novy Jicin		Czech Republic	741 01
69	Site Reference ID/Investigator# 37400	Novy Jicin		Czech Republic	741 01
70	Site Reference ID/Investigator# 37399	Obristvi		Czech Republic	277 42
71	Site Reference ID/Investigator# 37279	Olomouc		Czech Republic	772 00
72	Site Reference ID/Investigator# 37280	Olomouc		Czech Republic	772 00
73	Site Reference ID/Investigator# 37395	Pardubice		Czech Republic	530 03
74	Site Reference ID/Investigator# 47284	Plana		Czech Republic	348 15
75	Site Reference ID/Investigator# 37271	Plzen		Czech Republic	301 00
76	Site Reference ID/Investigator# 37273	Plzen		Czech Republic	304 11
77	Site Reference ID/Investigator# 37423	Plzen		Czech Republic	323 00
78	Site Reference ID/Investigator# 37431	Plzen		Czech Republic	326 00
79	Site Reference ID/Investigator# 37325	Podebrady		Czech Republic	290 01
80	Site Reference ID/Investigator# 47282	Podebrady		Czech Republic	290 01
81	Site Reference ID/Investigator# 37375	Prague 10		Czech Republic	100 00
82	Site Reference ID/Investigator# 37294	Prague 14		Czech Republic	198 00
83	Site Reference ID/Investigator# 37328	Prague 1		Czech Republic	141 00
84	Site Reference ID/Investigator# 37398	Prague 2		Czech Republic	120 00
85	Site Reference ID/Investigator# 37410	Prague 3		Czech Republic	130 00
86	Site Reference ID/Investigator# 37387	Prague 4		Czech Republic	140 00
87	Site Reference ID/Investigator# 37390	Prague 4		Czech Republic	140 00
88	Site Reference ID/Investigator# 43232	Prague 4		Czech Republic	140 00
89	Site Reference ID/Investigator# 43365	Prague 4		Czech Republic	140 00
90	Site Reference ID/Investigator# 43236	Prague 4		Czech Republic	142 00
91	Site Reference ID/Investigator# 37295	Prague 5		Czech Republic	150 00
92	Site Reference ID/Investigator# 37427	Prague 5		Czech Republic	158 00
93	Site Reference ID/Investigator# 37419	Prague 6		Czech Republic	163 00
94	Site Reference ID/Investigator# 37438	Prague 6		Czech Republic	169 00
95	Site Reference ID/Investigator# 37414	Prague 9		Czech Republic	190 00
96	Site Reference ID/Investigator# 47289	Prague 9		Czech Republic	190 00
97	Site Reference ID/Investigator# 37288	Prague		Czech Republic	141 00
98	Site Reference ID/Investigator# 37300	Prague		Czech Republic	141 00
99	Site Reference ID/Investigator# 37301	Prague		Czech Republic	141 00
100	Site Reference ID/Investigator# 37330	Prague		Czech Republic	141 00
101	Site Reference ID/Investigator# 37332	Prague		Czech Republic	141 00
102	Site Reference ID/Investigator# 37262	Prague		Czech Republic	149 00
103	Site Reference ID/Investigator# 37275	Prague		Czech Republic	160 00
104	Site Reference ID/Investigator# 37326	Prague		Czech Republic	181 00
105	Site Reference ID/Investigator# 37291	Prague		Czech Republic	198 00
106	Site Reference ID/Investigator# 37378	Pribor		Czech Republic	742 58
107	Site Reference ID/Investigator# 37412	Pribor		Czech Republic	742 58
108	Site Reference ID/Investigator# 37432	Pribram		Czech Republic	261 01
109	Site Reference ID/Investigator# 37425	Pribram		Czech Republic	261 95
110	Site Reference ID/Investigator# 37437	Prostejov		Czech Republic	796 01
111	Site Reference ID/Investigator# 37430	Prostejov		Czech Republic	796 04
112	Site Reference ID/Investigator# 37442	Rakovnik		Czech Republic	269 29
113	Site Reference ID/Investigator# 37393	Raspenava		Czech Republic	464 01
114	Site Reference ID/Investigator# 37421	Roznov pod Radhostem		Czech Republic	756 61
115	Site Reference ID/Investigator# 37287	Sadova		Czech Republic	612 00
116	Site Reference ID/Investigator# 37406	Slapanice		Czech Republic	664 51
117	Site Reference ID/Investigator# 37383	Steti		Czech Republic	41108
118	Site Reference ID/Investigator# 37278	Sumperk		Czech Republic	787 01
119	Site Reference ID/Investigator# 43223	Sumperk		Czech Republic	78701
120	Site Reference ID/Investigator# 43234	Sumperk		Czech Republic	78752
121	Site Reference ID/Investigator# 37285	Tachov		Czech Republic	347 42
122	Site Reference ID/Investigator# 37386	Teplice		Czech Republic	415 01
123	Site Reference ID/Investigator# 37264	Trebic		Czech Republic	674 01
124	Site Reference ID/Investigator# 37277	Trebic		Czech Republic	674 01
125	Site Reference ID/Investigator# 43231	Trebon		Czech Republic	379 01
126	Site Reference ID/Investigator# 37405	Trinec		Czech Republic	739 61
127	Site Reference ID/Investigator# 37265	Tyn nad Vltavou		Czech Republic	375 01
128	Site Reference ID/Investigator# 43366	Tyn		Czech Republic	375 01
129	Site Reference ID/Investigator# 37434	Uherske Hradiste		Czech Republic	686 01
130	Site Reference ID/Investigator# 37365	Uhersky Brod		Czech Republic	688 01
131	Site Reference ID/Investigator# 37284	Velke Pavlovice		Czech Republic	691 06
132	Site Reference ID/Investigator# 37385	Vlasim		Czech Republic	258 01
133	Site Reference ID/Investigator# 37322	Zamberk		Czech Republic	56421
134	Site Reference ID/Investigator# 37366	Zdar nad Sazavou		Czech Republic	591 01
135	Site Reference ID/Investigator# 43235	Zlin		Czech Republic	762 75

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Adam Hloska, M.D., Abbott Laboratories, s.r.o. (Czech Republic)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott
• ClinicalTrials.gov Identifier: NCT01130883
• Other Study ID Numbers: P12-109
• First Posted: May 26, 2010
• Last Update Posted: Sep 12, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Abbott: acute tracheitis; acute tracheobronchitis or acute bronchitis; acute exacerbation of chronic bronchitis; mild community-acquired pneumonia
• Additional relevant MeSH terms: Pneumonia; Bronchitis; Bronchitis, Chronic; Tracheitis; Acute Disease

Study Results

Participant Flow

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Period Title: Overall Study
STARTED	3130
Participants Analyzed	3128
COMPLETED	3120
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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 Participants	3130
Age, Customized (participants) [Number]
less than 18 years of age	2 0.1%
18 to 29 years of age	281 9%
30 to 39 years of age	544 17.4%
40 to 49 years of age	589 18.8%
50 to 59 years of age	680 21.7%
60 to 69 years of age	630 20.1%
70 to 79 years of age	305 9.7%
80 to 89 years of age	92 2.9%
90 years of age and older	7 0.2%
Sex/Gender, Customized (Number) [Number]
Number [Participants]	3130 100%
Region of Enrollment (participants) [Number]
Czech Republic	3130 100%

Outcome Measures

1. Primary Outcome

Title	Disappearance or Significant Alleviation of Symptoms
Description	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.
Time Frame	Day 8 - 16

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Number [Participants]	3109 99.3%

2. Primary Outcome

Title	Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician)
Description	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).
Time Frame	Day 0, Day 8 - 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Initial Visit - Auscultation Normal	956 30.5%
Initial Visit - Auscultation Abnormal	2146 68.6%
Initial Visit - Findings Not Reported	26 0.8%
Second Visit - Auscultation Normal	2768 88.4%
Second Visit - Auscultation Abnormal	247 7.9%
Second Visit - Findings Not Reported	113 3.6%

3. Secondary Outcome

Title	Body Temperature
Description	Number of participants in which body temperature was increased (temperature above 37 degrees Celsius).
Time Frame	Day 0, Day 8-16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Initial Visit - Temperature above 37 degrees C	2252 71.9%
Initial Visit - Temperature not above 37 degrees C	870 27.8%
Initial Visit - Temperature not reported	6 0.2%
Second Visit - Temperature above 37 degrees C	101 3.2%
Second Visit - Temperature not above 37 degrees C	3013 96.3%
Second Visit - Temperature not reported	14 0.4%

4. Secondary Outcome

Title	Bacteriological Investigation (if Available)
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	225
Haemophilus Influenzae	48 1.5%
Streptococcus pneumoniae	38 1.2%
Chlamydia pneumoniae	34 1.1%
Mycoplasma pneumoniae	14 0.4%
Haemophilus parainfluenzae	13 0.4%
Klebsiella pneumoniae	12 0.4%
Haemophilus species	10 0.3%
Staphylococcus aureus	5 0.2%
Branhamella catarrhalis	5 0.2%

5. Secondary Outcome

Title	Cough and Its Character
Description	Number of participants in which cough was present, and if present, type of cough (irritating, productive, both or not reported)
Time Frame	Day 0, Day 8-16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Initial Visit - Presence of cough	2942 94%
a) Irritating cough	1601 51.2%
b) Productive cough	1177 37.6%
c) Both irritating and productive	157 5%
d) Not Reported	7 0.2%
Initial Visit - Cough not present	186 5.9%
Second Visit - Presence of cough	556 17.8%
a) Irritating cough	187 6%
b) Productive cough	351 11.2%
c) Both irritating and productive	16 0.5%
d) Not Reported	2 0.1%
Second Visit - Cough not present	2572 82.2%

6. Secondary Outcome

Title	Dyspnea and Its Type
Description	Presence of dyspnea (difficulty breathing) and type of dyspnea (exertional, resting, both, or not reported).
Time Frame	Day 0, Day 8-16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Initial Visit - Presence of dyspnea	1091 34.9%
a) Exertional	794 25.4%
b) Resting	235 7.5%
c) Both exertional and resting	60 1.9%
d) Type of dyspnea not reported	2 0.1%
Initial Visit - Dyspnea not present	2037 65.1%
Second Visit - Presence of dyspnea	262 8.4%
a) Exertional	234 7.5%
b) Resting	17 0.5%
c) Both exertional and resting	9 0.3%
d) Type of dyspnea not reported	2 0.1%
Second Visit - Dyspnea not present	2866 91.6%

7. Secondary Outcome

Title	Auscultation
Description	Participants with abnormal auscultation findings (abnormal breath sounds) and type of findings (wheezing, crackles, both, or not reported).
Time Frame	Day 0, Day 8-16

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Initial Visit - Abnormal Auscultaton findings	2146 68.6%
a) Wheezing	1577 50.4%
b) Crackles	408 13%
c) Both wheezing and crackles	145 4.6%
d) Not reported	16 0.5%
Second Visit - Abnormal Auscultation findings	247 7.9%
a) Wheezing	187 6%
b) Crackles	54 1.7%
c) Both wheezing and crackles	4 0.1%
d) Not reported	2 0.1%

8. Secondary Outcome

Title	Chest X-ray in Case of Community-Acquired Pneumonia (CAP)
Description	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.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	294
Findings indicative of pneumonia	276 8.8%
Findings not indicative of pneumonia	18 0.6%

9. Secondary Outcome

Title	Study Drug Given as the First, Second or Third Antimicrobial Treatment
Description	Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Time Frame	Day 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Klacid SR as first antimicrobial treatment	2910 93%
Klacid SR as second antimicrobial treatment	216 6.9%
Klacid SR as third antimicrobial treatment	2 0.1%

10. Secondary Outcome

Title	Compliance
Description	Number of participants who took their medication according to the prescribed regimen (dose and duration) during the study.
Time Frame	Day 8 - 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Number [Participants]	3122 99.7%

11. Secondary Outcome

Title	Termination of Treatment Due to Noncompliance
Description	Number of participants who discontinued Klacid SR treatment early due to noncompliance with the recommended study medication regimen.
Time Frame	Day 8 - 16

Outcome Measure Data

Analysis Population Description

A total of 3128 participants were included in the analysis.

Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
Measure Participants	3128
Number [Participants]	6 0.2%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Investigator monitored study participants for adverse events as per usual practice.
Arm/Group Title	Klacid SR Treatment
Arm/Group Description	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.
All Cause Mortality
	Klacid SR Treatment
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Klacid SR Treatment
	Affected / at Risk (%)	# Events
Total	2/3128 (0.1%)
Infections and infestations
Tuberculosis pleuritis	1/3128 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary tumor	1/3128 (0%)
Other (Not Including Serious) Adverse Events
	Klacid SR Treatment
	Affected / at Risk (%)	# Events
Total	7/3128 (0.2%)
Gastrointestinal disorders
Bad taste in mouth	1/3128 (0%)
Burning tongue	1/3128 (0%)
Bitter taste in mouth	1/3128 (0%)
Diarrhea	3/3128 (0.1%)
Dyspepsia	1/3128 (0%)
Gastrointestinal tract symptoms	1/3128 (0%)
Nausea	1/3128 (0%)
Vomiting	1/3128 (0%)
General disorders
Loss of appetite	1/3128 (0%)

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.