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Recovery Time in Thai Patients With Upper or Lower Respiratory Tract Infections Treated With Klacid MR

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01076153
First received: February 24, 2010
Last updated: July 1, 2011
Last verified: June 2011
Results First Received: April 22, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Respiratory Tract Infection
Intervention: Drug: Clarithromycin (Klacid® MR)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 760 participants were enrolled in the study. 694 were analyzed as 66 participants had protocol deviations (some more than 1): Age less than 18 years (22), took excluded drugs (17), took Klacid more than 14 days (16), took Klacid less than 5 days (11), added 250 mg Klacid to Klacid MR (5), and used injectable drugs (3).

Reporting Groups
  Description
Klacid MR Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.

Participant Flow:   Overall Study
    Klacid MR  
STARTED     760  
COMPLETED     749  
NOT COMPLETED     11  
Symptoms improved/resolved                 10  
Adverse Event                 1  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Klacid MR The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.

Baseline Measures
    Klacid MR  
Number of Participants  
[units: participants]
  694  
Age [1]
[units: years]
Mean ± Standard Deviation
  41.16  ± 14.22  
Age, Customized [1]
[units: participants]
 
18 to 20 years     28  
21 to 30 years     154  
31 to 40 years     204  
41 to 50 years     141  
51 to 60 years     102  
Over 60 years     65  
Gender [1]
[units: participants]
 
Female     404  
Male     290  
Region of Enrollment [1]
[units: participants]
 
Thailand     694  
Diagnosis [2]
[units: participants]
 
Upper respiratory tract infection     510  
Lower respiratory tract infection     165  
Both upper and lower respiratory tract infections     19  
Risk factor: Smoking status [3]
[units: participants]
 
Participant was a smoker     164  
Participant did not smoke     530  
[1] Based on per-protocol population (694 participants).
[2] Participant diagnosis at study entry for the per-protocol population (694 participants).
[3] Whether or not participants smoked cigarettes for the per-protocol population (694 participants).



  Outcome Measures
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1.  Primary:   Average Time From Baseline to Recovery From Cough and Other Symptoms   [ Time Frame: Baseline to 14 days ]

2.  Secondary:   Number and Type of Adverse Events   [ Time Frame: Baseline to 14 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT01076153     History of Changes
Other Study ID Numbers: P08-331
Study First Received: February 24, 2010
Results First Received: April 22, 2011
Last Updated: July 1, 2011
Health Authority: Thailand: Food and Drug Administration