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Trial record 9 of 389 for:    CLARITHROMYCIN

Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER) (CLOSER)

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ClinicalTrials.gov Identifier: NCT01075204
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : January 30, 2013
Last Update Posted : February 12, 2013
Sponsor:
Collaborator:
Eilaf CRO
Information provided by (Responsible Party):
Abbott

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Respiratory Tract Infection
Intervention Drug: clarithromycin modified release 500 mg
Enrollment 335
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Period Title: Overall Study
Started 335
Completed 335
Not Completed 0
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Baseline Participants 335
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 335 participants
35.48  (12.552)
[1]
Measure Description: Age data provided for 330 participants.
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 335 participants
Male 205
Female 122
Missing 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 335 participants
Egypt 120
Saudi Arabia 215
1.Primary Outcome
Title Percentage of Participants With a Fast Recovery
Hide Description

Fast recovery is defined as the resolution of symptoms within 5 days or less from the start of clarithromycin modified release treatment. Recovery is defined as returning to the symptom status prior to the onset of the respiratory tract infection, based on the participant and physician's assessment.

Data are reported for all symptoms taken together (all symptoms resolved within 5 days) and for each individual symptom.

Time Frame Day 1 to Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants. For the individual symptoms, N indicates the number of participants with that symptom at Baseline and with available recovery data.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
All symptoms together [N=335] 12.8
Fever response [N=184] 54.3
Cough response [N=215] 27.4
Sputum response [N=212] 29.7
Dyspnea response [N=62] 37.1
Abnormal breath sounds response [N=47] 42.6
Rhinorrhea response [N=113] 28.3
Nasal congestion response [N=233] 33.5
Post-nasal discharge response [N=178] 18.5
Sneezing response [N=87] 25.3
Sore throat response [N=200] 38.0
Painful swallowing response [N=162] 38.9
Itchy watery eye response [N=33] 6.1
Malaise response [N=68] 30.9
Myalgia response [N=79] 34.2
2.Primary Outcome
Title Percentage of Participants With Clinical Success
Hide Description Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
86.9
(83.28 to 90.52)
3.Primary Outcome
Title Classification of Overall Response
Hide Description

Based on the participant and physician's assessment, overall symptom response was classified as follows:

  • Fast Responders: participants showing clinical recovery of all symptoms within the first 5 days of treatment.
  • Slow Responders: participants showing clinical recovery between Day 6 & Day 10 (includes participants with a fast response for some symptoms and slow response for the remaining symptoms).
  • Failure response: participants showing no clinical success by Day 10, or showing need for another anti-infective treatment to resolve aggravated symptoms (includes participants with a failure response for some symptoms and either a slow or fast response for the remaining symptoms).
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Fast responders 43
Slow responders 248
Failure response 44
4.Secondary Outcome
Title Percentage of Participants With Treatment Failure
Hide Description

Treatment failure is defined as failure to return to baseline symptom status (symptom status prior to the onset of the respiratory tract infection) within 10 days or the need for new treatments or medications during the first 10 days for persistence or aggravation of symptoms.

Participants with treatment failure were further categorized as:

  • All symptoms improved but not resolved within the study period;
  • Some symptoms improved and some resolved;
  • Some symptoms resolved or improved while other symptoms did not improve (unchanged);
  • Some symptoms resolved or improved while other symptoms became worse.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
Treatment failure total 13.1
All symptoms improved but not resolved 0.9
Some symptoms improved and some resolved 3.9
Some symptoms resolved/improved, others unchanged 6.9
Some symptoms resolved/improved/others worsened 1.5
5.Secondary Outcome
Title Factors Affecting the Speed of Recovery
Hide Description Factors affecting the speed of recovery were examined and tested for association with the speed of recovery. Logistic regression was conducted to assess whether the following nine variables; age, gender, body mass index (BMI), concomitant tobacco use, steroid use, bronchial asthma, allergic rhinitis, nasal septum deviation and chronic obstructive pulmonary disease (COPD) act as predictors for speed of recovery of respiratory tract infections. Data shown are the beta regression coefficients for each variable.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: coefficient
Age -0.007
Gender 0.216
Body mass index (BMI) 0.004
Tobacco use 0.419
Steroid use -0.456
Bronchial asthma 0.140
Allergic rhinitis 19.292
Nasal septum deviation 18.698
Chronic obstructive pulmonary disease (COPD) 19.281
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clarithromycin Modified Release
Comments Logistic regression: Omnibus Test of Model Coefficients (all the nine variables are considered together).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments [Not Specified]
Method Chi-squared
Comments 9 degrees of freedom.
6.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description

An adverse event (AE) is defined as any untoward medical occurrence in a patient, which does not necessarily have a causal relationship with their treatment.

If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE):

Results in death or is life-threatening, results in admission or prolongation of hospitalization, is a congenital anomaly or persistent or significant disability/incapacity or is an important medical event requiring medical or surgical intervention to prevent any of the outcomes listed above.

Please see Adverse Events section below for more details.

Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Any adverse event 2
Serious adverse event 0
7.Secondary Outcome
Title Fever Status at End of Study
Hide Description Participants with fever (temperature over 37.0 degree of Celsius) at any time during the study were classified at the end of study as resolved, improved or no change. 'No fever' indicates participants with no fever during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Resolved 120
Improved 70
No change 5
No fever 140
8.Secondary Outcome
Title Cough Status at End of Study
Hide Description Participants with cough at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No cough' indicates participants with no cough symptoms during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients with cough data available.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: participants
Resolved 93
Improved 100
No change 23
Worsened 4
No cough 113
9.Secondary Outcome
Title Sputum Status at End of Study
Hide Description Participants with sputum symptoms at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No sputum' indicates participants with no sputum symptoms during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients with sputum data available.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: participants
Resolved 88
Improved 102
No change 19
Worsened 4
No sputum 120
10.Secondary Outcome
Title Dyspnea Status at End of Study
Hide Description Participants with dyspnea (shortness of breath) at any time during the study were classified at the end of study as resolved, improved, became worse, or no change. 'No dyspnea' indicates participants with no dyspnea symptoms during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Resolved 31
Improved 28
No change 2
Worsened 1
No dyspnea 273
11.Secondary Outcome
Title Abnormal Breathing Sounds Status at End of Study
Hide Description Participants with abnormal breathing sounds such as wheezing or rales at any time during the study were classified at the end of study as resolved, improved, or no change. 'No abnormal breath sounds' indicates participants with no abnormal breathing sounds during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Resolved 30
Improved 13
No change 4
No abnormal breath sounds 288
12.Secondary Outcome
Title Rhinorrhea Status at End of Study
Hide Description Participants with rhinorrhea (runny nose) at any time during the study were classified at the end of study as resolved, or no change. 'No rhinorrhea' indicates participants with no rhinorrhea during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: participants
Resolved 55
Improved 56
No change 2
No rhinorrhea 222
13.Secondary Outcome
Title Post-nasal Discharge Status at End of Study
Hide Description Participants with post-nasal discharge at any time during the study were classified at the end of study as resolved, improved, or no change. 'No post-nasal discharge' indicates participants with no post-nasal discharge symptoms during the study period.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled patients with post-nasal discharge data available.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 333
Measure Type: Number
Unit of Measure: participants
Resolved 75
Improved 98
No change 6
No post-nasal discharge 154
14.Secondary Outcome
Title Percentage of Participants Compliant With Treatment
Hide Description Treatment compliance was assessed by the study physician at each study visit. The percentage of participants who were compliant with study treatment for 6 days, 7 days and 8 days is reported.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled patients.
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description:
Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
Overall Number of Participants Analyzed 335
Measure Type: Number
Unit of Measure: percentage of participants
6 days 43
7 days 54
8 days 3
Time Frame 10 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clarithromycin Modified Release
Hide Arm/Group Description Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
All-Cause Mortality
Clarithromycin Modified Release
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Clarithromycin Modified Release
Affected / at Risk (%)
Total   0/335 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clarithromycin Modified Release
Affected / at Risk (%)
Total   2/335 (0.60%) 
Gastrointestinal disorders   
Dyspepsia  1  1/335 (0.30%) 
Diarrhea  1  1/335 (0.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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
Layout table for Results Point of Contact information
Name/Title: Esther Oppermann, Clinical Trial Manager
Organization: Abbott
Phone: 49 511 6750 3954
EMail: esther.oppermann@abbott.com
Layout table for additonal information
Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01075204     History of Changes
Other Study ID Numbers: P11-989
First Submitted: February 23, 2010
First Posted: February 25, 2010
Results First Submitted: December 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: February 12, 2013