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

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ClinicalTrials.gov Identifier: NCT01076153
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : June 29, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Respiratory Tract Infection
Intervention Drug: Clarithromycin (Klacid® MR)
Enrollment 760
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Klacid MR
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 760
Completed 749
Not Completed 11
Reason Not Completed
Symptoms improved/resolved             10
Adverse Event             1
Arm/Group Title Klacid MR
Hide Arm/Group Description The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
Overall Number of Baseline Participants 694
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 694 participants
41.16  (14.22)
[1]
Measure Description: Based on per-protocol population (694 participants).
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 694 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
[1]
Measure Description: Based on per-protocol population (694 participants).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 694 participants
Female
404
  58.2%
Male
290
  41.8%
[1]
Measure Description: Based on per-protocol population (694 participants).
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Thailand Number Analyzed 694 participants
694
[1]
Measure Description: Based on per-protocol population (694 participants).
Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 694 participants
Upper respiratory tract infection 510
Lower respiratory tract infection 165
Both upper and lower respiratory tract infections 19
[1]
Measure Description: Participant diagnosis at study entry for the per-protocol population (694 participants).
Risk factor: Smoking status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 694 participants
Participant was a smoker 164
Participant did not smoke 530
[1]
Measure Description: Whether or not participants smoked cigarettes for the per-protocol population (694 participants).
1.Primary Outcome
Title Average Time From Baseline to Recovery From Cough and Other Symptoms
Hide Description Study participants were seen at an initial visit (baseline) and received Klacid treatment for 5 to 14 days. A medical appointment (visit or phone call) was made 6 to 14 days after the first visit. Participants' symptoms were rated using one of the following categories: resolved, improved, not changed, or worse. Associated dates were also recorded. Symptoms included, but were not limited to, cough, fever, and sore throat. Recovery was defined as the disappearance of all signs and symptoms of infection.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The per-protocol population consisted of 694 participants as 66 participants were excluded for 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).
Arm/Group Title Klacid MR (Total Number Recovered) Klacid MR (URTI, Recovered) Klacid MR (LRTI, Recovered) Klacid MR (URTI and LRTI, Recovered)
Hide Arm/Group Description:
Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
Overall Number of Participants Analyzed 658 491 148 19
Mean (Standard Deviation)
Unit of Measure: Days
7.06  (2.65) 6.76  (2.11) 7.82  (3.75) 9.05  (3.08)
2.Secondary Outcome
Title Number and Type of Adverse Events
Hide Description Adverse events were collected during the course of the study up to 30 days or 5 half-lives following the last dose of Klacid. The number of participants experiencing a serious or non-serious adverse event is summarized. See the Reported Adverse Event section for details.
Time Frame Baseline to 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population included all participants who took at least 1 dose of Klacid.
Arm/Group Title Klacid MR
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 760
Measure Type: Number
Unit of Measure: Events
Serious Adverse Events 0
Non-serious Adverse Events 7
Time Frame All adverse events that occurred during the course of the study were reported in detail on case report forms. Adverse events occurring during the study were reported up to 30 days or 5 half-lives after the last dose of Klacid MR.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Klacid MR
Hide Arm/Group Description 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.
All-Cause Mortality
Klacid MR
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Klacid MR
Affected / at Risk (%) # Events
Total   0/760 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Klacid MR
Affected / at Risk (%) # Events
Total   5/760 (0.66%)    
Cardiac disorders   
Palpitations  1  1/760 (0.13%)  1
Gastrointestinal disorders   
Dysgeusia  1  3/760 (0.39%)  4
Abdominal pain  1  1/760 (0.13%)  1
Musculoskeletal and connective tissue disorders   
Muscle strain  1  1/760 (0.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
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.
Results Point of Contact
Name/Title: Global Medical Services
Organization: Abbott
Phone: 1-800-633-9110
Responsible Party: Savary Om/ Regional Medical Director, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT01076153     History of Changes
Other Study ID Numbers: P08-331
First Submitted: February 24, 2010
First Posted: February 26, 2010
Results First Submitted: April 22, 2011
Results First Posted: June 29, 2011
Last Update Posted: July 12, 2011