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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott

ClinicalTrials.gov Identifier:

NCT01130883

First received: May 6, 2010

Last updated: September 8, 2011

Last verified: September 2011

History of Changes

Results First Received: July 25, 2011

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Conditions:	Tracheitis Tracheobronchitis Bronchitis Chronic Bronchitis Community-Acquired Pneumonia (CAP)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Klacid SR Treatment	Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.

Participant Flow: Overall Study

	Klacid SR Treatment
STARTED	3130
Participants Analyzed	3128
COMPLETED	3120
NOT COMPLETED	10
Patient Noncompliance	6
Reason Unknown	1
Adverse Event	3

Baseline Characteristics

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Reporting Groups

	Description
Klacid SR Treatment	Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.

Baseline Measures

	Klacid SR Treatment
Number of Participants [units: participants]	3130
Age, Customized [units: participants]
less than 18 years of age	2
18 to 29 years of age	281
30 to 39 years of age	544
40 to 49 years of age	589
50 to 59 years of age	680
60 to 69 years of age	630
70 to 79 years of age	305
80 to 89 years of age	92
90 years of age and older	7
Gender, Customized ^[1] [units: Participants]	3130
Region of Enrollment [units: participants]
Czech Republic	3130

[1]	Gender was not reported in this study.

Outcome Measures

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1. Primary:

Disappearance or Significant Alleviation of Symptoms [ Time Frame: Day 8 - 16 ]

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2. Primary:

Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) [ Time Frame: Day 0, Day 8 - 16 ]

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3. Secondary:

Body Temperature [ Time Frame: Day 0, Day 8-16 ]

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4. Secondary:

Bacteriological Investigation (if Available) [ Time Frame: Day 0 ]

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5. Secondary:

Cough and Its Character [ Time Frame: Day 0, Day 8-16 ]

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6. Secondary:

Dyspnea and Its Type [ Time Frame: Day 0, Day 8-16 ]

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7. Secondary:

Auscultation [ Time Frame: Day 0, Day 8-16 ]

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8. Secondary:

Chest X-ray in Case of Community-Acquired Pneumonia (CAP) [ Time Frame: Day 0 ]

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9. Secondary:

Study Drug Given as the First, Second or Third Antimicrobial Treatment [ Time Frame: Day 0 ]

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Measure Type	Secondary
Measure Title	Study Drug Given as the First, Second or Third Antimicrobial Treatment
Measure Description	Number of participants who received Klacid SR as the first, second or third (further) antimicrobial agent.
Time Frame	Day 0
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Klacid SR Treatment	Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.

Measured Values

	Klacid SR Treatment
Number of Participants Analyzed [units: participants]	3128
Study Drug Given as the First, Second or Third Antimicrobial Treatment [units: Participants]
Klacid SR as first antimicrobial treatment	2910
Klacid SR as second antimicrobial treatment	216
Klacid SR as third antimicrobial treatment	2

No statistical analysis provided for Study Drug Given as the First, Second or Third Antimicrobial Treatment

10. Secondary:

Compliance [ Time Frame: Day 8 - 16 ]

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11. Secondary:

Termination of Treatment Due to Noncompliance [ Time Frame: Day 8 - 16 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Abbott
ClinicalTrials.gov Identifier:	NCT01130883 History of Changes
Other Study ID Numbers:	P12-109
Study First Received:	May 6, 2010
Results First Received:	July 25, 2011
Last Updated:	September 8, 2011
Health Authority:	Czech Republic: State Institute for Drug Control

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