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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infection
• Intervention / Treatment: Drug: clarithromycin modified release 500 mg

• Study Type: Observational
• Enrollment (Actual): 335

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Site Ref # / Investigator 50162
  • Cairo, Egypt
    • Site Ref # / Investigator 50215
  • Cairo, Egypt
    • Site Ref # / Investigator 50225
  • Cairo, Egypt
    • Site Ref # / Investigator 50235
  • Cairo, Egypt
    • Site Ref # / Investigator 50236
  • Cairo, Egypt
    • Site Ref # / Investigator 50237
  • Cairo, Egypt
    • Site Ref # / Investigator 51204
  • Cairo, Egypt
    • Site Ref # / Investigator 51205
  • Helwan, Egypt
    • Site Ref # / Investigator 50213
  • Tanta, Egypt
    • Site Ref # / Investigator 51206
  • Tanta, Egypt
    • Site Ref # / Investigator 51207
• Saudi Arabia
  • Jeddah, Saudi Arabia, 21461
    • Site Ref # / Investigator 22543

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: clarithromycin modified release 500 mg; clarithromycin modified release 500 mg for 7 days; Other Names: Clarithromycin Modified Release 500 mg (Klacid XL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Fast Recovery	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.	Day 1 to Day 5
Percentage of Participants With Clinical Success	Clinical success is defined as the disappearance of cough and other symptoms within 10 days or less from the start of clarithromycin treatment.	10 days
Classification of Overall Response	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).	10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment Failure	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.	10 days
Factors Affecting the Speed of Recovery	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.	10 days
Number of Participants With Adverse Events	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.	10 days
Fever Status at End of Study	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.	10 days
Cough Status at End of Study	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.	10 days
Sputum Status at End of Study	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.	10 days
Dyspnea Status at End of Study	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.	10 days
Abnormal Breathing Sounds Status at End of Study	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.	10 days
Rhinorrhea Status at End of Study	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.	10 days
Post-nasal Discharge Status at End of Study	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.	10 days
Percentage of Participants Compliant With Treatment	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.	10 days

Collaborators and Investigators

• Sponsor: Abbott
• Collaborators: Eilaf
• Investigators: Study Director: Mohamed Tahoun, Bachelor, Abbott Laboratories - Saudi Arabia

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 12, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Recovery; Clarithromycin; Respiratory Tract Infection
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: P11-989