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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
Information provided by (Responsible Party):
Abbott

Tracking Information
First Submitted Date February 23, 2010
First Posted Date February 25, 2010
Results First Submitted Date December 20, 2012
Results First Posted Date January 30, 2013
Last Update Posted Date February 12, 2013
Study Start Date January 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2012)
  • Percentage of Participants With a Fast Recovery [ Time Frame: Day 1 to Day 5 ]
    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.
  • Percentage of Participants With Clinical Success [ Time Frame: 10 days ]
    Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.
  • Classification of Overall Response [ Time Frame: 10 days ]
    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).
Original Primary Outcome Measures
 (submitted: February 23, 2010)
Time to recovery (defined as the number of days required to return to baseline after initiation of Klacid). Baseline is defined as the symptom status prior to the onset of RTI. Fast recovery is less than or equal to 5 days from start of Klacid therapy. [ Time Frame: 10 days ]
Change History
Current Secondary Outcome Measures
 (submitted: December 20, 2012)
  • Percentage of Participants With Treatment Failure [ Time Frame: 10 days ]
    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.
  • Factors Affecting the Speed of Recovery [ Time Frame: 10 days ]
    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.
  • Number of Participants With Adverse Events [ Time Frame: 10 days ]
    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.
  • Fever Status at End of Study [ Time Frame: 10 days ]
    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.
  • Cough Status at End of Study [ Time Frame: 10 days ]
    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.
  • Sputum Status at End of Study [ Time Frame: 10 days ]
    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.
  • Dyspnea Status at End of Study [ Time Frame: 10 days ]
    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.
  • Abnormal Breathing Sounds Status at End of Study [ Time Frame: 10 days ]
    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.
  • Rhinorrhea Status at End of Study [ Time Frame: 10 days ]
    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.
  • Post-nasal Discharge Status at End of Study [ Time Frame: 10 days ]
    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.
  • Percentage of Participants Compliant With Treatment [ Time Frame: 10 days ]
    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.
Original Secondary Outcome Measures
 (submitted: February 23, 2010)
  • Adverse Events: record the number, symptoms and severity of adverse events for Klacid XL. The action taken, outcome and relationship to Klacid XL treatment should be addressed. [ Time Frame: 10 days ]
  • Percentage of treatment failure:defined as failure to return to baseline before 10 days or the requirement of new treatments or medications during the first 10 days for persistence or aggravation of symptoms. [ Time Frame: 10 days ]
  • Factors affecting the speed of recovery:identifying variables independently and significantly associated with the speed of recovery. [ Time Frame: 10 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Official Title Clarithromycin Modified Release Observational Study for Evaluation of Treatment, Tolerability & Recovery Time in Saudi & Egyptian Clinical Settings (CLOSER)
Brief Summary The objective is to describe the time to recovery of symptoms (cough, mucus, fever, sore throat, and others), tolerability and compliance of treatment with clarithromycin once daily in patients with upper or lower respiratory tract infections in the routine clinical practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Assignment to clarithromycin therapy falls within current clinical practice and was not decided in advance by this protocol. Study participants were selected from patients seen at the primary care clinic, with a preliminary clinical diagnosis of an upper or lower respiratory tract infection who were considered for antibiotic treatment and prescribed clarithromycin.
Condition Respiratory Tract Infection
Intervention Drug: clarithromycin modified release 500 mg
clarithromycin modified release 500 mg for 7 days
Other Name: Clarithromycin Modified Release 500 mg (Klacid XL)
Study Groups/Cohorts Clarithromycin modified release
Patients 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.
Intervention: Drug: clarithromycin modified release 500 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 20, 2012)
335
Original Estimated Enrollment
 (submitted: February 23, 2010)
300
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults, equal to or more than 18 years years of age
  • Patients with respiratory tract infections, including any of the following:

    • Acute tracheitis, acute tracheobronchitis
    • Acute sinusitis
    • Chronic sinusitis
    • Acute tonsillopharyngitis
    • Acute bronchitis
    • Mild community-acquired pneumonia
    • Acute exacerbation of chronic bronchitis

Exclusion Criteria:

  • Known hypersensitivity to or previously intolerant of macrolides.
  • Illness severe enough to warrant hospitalization or parenteral therapy.
  • Concomitant use of any of the following medications:

    • Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine.
    • Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate.
    • Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir.
  • Severe immunodeficiency and chronic disease conditions.
  • Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm).
  • Mental condition rendering the subject unable to understand the nature of the study.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt,   Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01075204
Other Study ID Numbers P11-989
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Abbott
Study Sponsor Abbott
Collaborators Eilaf
Investigators
Study Director: Mohamed Tahoun, Bachelor Abbott Laboratories - Saudi Arabia
PRS Account Abbott
Verification Date February 2013